ARTHREX, INC.

FDA Device Registration & Listing · Naples, FL, US · Registration 1220246

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1220246
FEI Number
1220246
Entity Name
ARTHREX, INC.
City/State/Country
Naples, FL, US
Establishment Address
1370 Creekside Blvd, Naples, FL 34108, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ARTHREX, INC. (Owner Number: 1220287)
Owner / Operator Contact Address
1370 CREEKSIDE BLVD., --, Naples, FL 34108, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K060233
PMA Number
N/A

All Registered Proprietary Names

Arthrex MicroSuture Anchors orthopedic manual instrument Pin, Fixation, Smooth orthopedic manual instrument BIOCOMPOSITE Dressing, Compression Elastic bandage DOUBLE SYRINGE (ACP) SYSTEM Arthrex PushLock VARIOUS BURS Arthrex PCL TightRope FIBERTAPE smooth or threaded metallic bone fixation fastener Arthrex FiberTak Suture Anchors OPES ELECTRODES AND ACCESSORIES RF device, blade, hook ARTHROSCOPY LEG HOLDER Arthrex SwiveLock Anchors Suction Lipoplasty Accessories Camera, Television, Surgical, Without Audio Mallet ARTHROSCOPY PUMP Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System Manual surgical instrument for general use. ACL TightRope Double Bundle ACCIN Uni-Knee System BIO-PIN ACCIN Uni-Knee System Arthrex Tibial GraftBolt WASHER SHAVER SYSTEM General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure BIO-CORKSCREW FT EXTERNAL FIXATOR SYSTEM COBE Angel Whole Blood Separation System Instrument, Special Lens, For Endoscope ACCIN Total Knee System FiberTak DR iBalance Syringe, piston BI-CORTICAL BIO-POST AND WASHER Arthrex Low Profile Screws orthopedic manual instrument single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes Arthrex SwiveLock Anchors smooth or threaded metallic bone fixation fastener orthopedic manual instrument Arthrex Small External Fixation System Adaptor, Holder, Syringe Arthrex SwiveLock Anchors saw blade AESCULAP STERILCONTAINER SYSTEM Arthrex Fracture System FiberTape Fiberstick FiberWire AOS HUMERAL NAI Graft Delivery Device with Integrated Stylet BIOCOMPOSITE SUTURE ANCHORS Arthrex Univers II Glenoid Components Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener Forceps, General & Plastic Surgery ACCIN Patellofemoral System SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) Arthroscope Sheath DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER PUSHLOCK HATRIC CONTINUOUS WAVE III drill bit ACL TightRope SHAVER BLADES ACCIN Bipolar Head System BIO-COMPRESSION SCREW display, cathode-ray tube, medical Arthrex Graft-Anchor Laproscopes UNIVERS SHOULDER Insufflator 50L FM134 TRIM-IT FAMILY Arthrex BioSuture Nonabsorbable poly(ethylene terephthalate) Surgical Suture WASHER Sutter CURIS RF Generator fixation plate SHOULDER HOLDER Apparatus, Traction, Non-Powered Orthopedic manual surgical instrument, Passer Arthrex Univers Apex Shoulder joint metal/ polymer semi-constrained cemented prosthesis Arthrex Low Profile Screws Metallic Bone Fixation Biosync Bone wedge Biosync Fastener, Fixation, nondegradable, soft tissue Fracture Plates & Screws SUPPORT, PATIENT POSITION APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Arthrex Suture orthopedic manual instrument MINI TIGHTROPE Wrench Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories LATERAL SUPERIOR CLAVICLE PLATE LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE LEFT AND RIGHT; ANTERIOR CLAVICLE PLA ARTHROERESIS IMPLANT Arrowhead Mini-Rail Fixator INTERFERENCE SCREWS Arthrex Univers II Shoulder Prosthesis orthopedic manual instrument Arthroscope Bio-Composite SutureTak Thrombinator System for use with the Arthrex Angel Concentrated Platelet Rich Plasma (PRP)System cart, emergency, cardiopulmonary Stimublast Arthrex Pushlock SUTTER ELECTROSURGICAL CABLES INTERFERENCE SCREW TENODESIS FAMILY Arthrex Biocomposite Transfix orthopedic manual instrument elevator, surgical, general & plastic surgery Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi HUMERAL FRACTURE PLATE orthopedic manual instrument COMPRESSION STAPLE BIOCOMPOSITE INTERFERENCE SCREW Arthroscope Arthrex iBalance BiCompartmental Arthroplasty System Arthrex Plates, Screws, and Staples Holder, Camera, Surgical Arthrex iBalance TKA System Knee Joint Patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Arthrex Fracture Plates Orthopedic Template RETROBUTTON Driver, Prosthesis TAK FAMILY FIBERWIRE BUTTON REPAIR KIT UNIVERS FRACTURE BIO-FASTAK SUTURE ANCHOR DOLPHIX EXTERNAL FIXATION SYSTEM TWISTER, WIRE Arthrex Tibial GraftBolt Pliers, Surgical EXTERNAL FIXATION CLAMP 5 MM PIN X9.5MM ROD MODEL 1151-100 EXTERNAL FIXATON CLAMP 9.5MM ROD 40 L HIGH FLOW INSUFFLATOR F108 Viscogel/Viscospray BIO-BUTTON Instrument, manual, surgical, general use Procellera Composite Antibacterial Wound Dressing Accessories for the SixFix® Hexapod Fixator BENDER Single/multiple component metallic bone fixation appliances and accessories Arthrex Ankle Fusion Plating System Catheter, Irrigation handle, scalpel knee joint patellofemorotibial polymer/metal/polymer semi-constrained Arthrex iBalance Patella Implant, Dome OSTEOTOMY SYSTEM ORTHOPEDIC MANUAL INSTRUMENTS VARIOUS INSTRUMENTS Arthroscope Arthrex Minimally Invasive Ankle Fusion Plate Single/multiple component metallic bone fixation appliances and accessories Arthrex Compression Plates DISCOSCOPES, CERVICAL ENDOSCOPES fixation plate LOW PROFILE PLATE AND SCREW SYSTEM Univers II Forceps, Rongeur, Surgical EXTERNAL FIXATOR ST.A R 90 F4

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-09-14
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2011-09-14
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2011-09-14
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2017-11-15
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2017-11-15
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-11-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-07-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-31
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-07-31
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1996-08-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-05-30
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2019-12-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-05-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-05-17
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-05-17
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-08-22
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-08-22
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2025-08-22
HXB Probe Orthopedic Class 1 888.4540 2003-08-07
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-04-17
MHW Dressing, Compression General Hospital Class 1 880.5075 2014-01-08
FMF Syringe, Piston General Hospital Class 2 880.5860 2009-04-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-03-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-03-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-03-26
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-03-26
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2018-04-03
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-04-03
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-04-03
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-03-28
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2018-10-05
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-10-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-08-24
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-08-24
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2026-03-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-10-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-10-18
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2007-08-23
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2025-11-19
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-11-19
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2011-05-31
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2011-05-31
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-11-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2014-08-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-11-26
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-01-11
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2011-01-11
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2025-01-09
FWB Camera, Television, Surgical, Without Audio General, Plastic Surgery Class 1 878.4160 2024-07-25
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2019-11-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-11-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-11-06
HXL Mallet General, Plastic Surgery Class 1 878.4800 2024-08-29
HRX Arthroscope Orthopedic Class 2 888.1100 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-10-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-10
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-01-14
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2015-02-09
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2022-02-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-01-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-01-05
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2011-01-17
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2011-01-17
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2011-01-17
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2014-08-25
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2011-10-17
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-11-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-09-12
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2011-10-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2010-04-13
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-08-23
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2016-02-24
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2016-02-24
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2016-02-24
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2008-11-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-12-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-09-09
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2021-08-30
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-08-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-07-08
NDK System, External Fixator (With Metallic Invasive Components) Orthopedic Class 2 888.3040 2021-12-20
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2020-12-17
FEI Instrument, Special Lens, For Endoscope Gastroenterology, Urology Class 1 876.1500 2017-01-25
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2011-10-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-05-13
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2020-04-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-06-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-06-30
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2021-11-19
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2020-09-03
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2016-12-19
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2016-12-19
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2019-12-18
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-12-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2010-03-29
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-08-23
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-05-18
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-05-18
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-05-18
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-19
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2003-08-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-07-28
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2014-03-21
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-11-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-08-30
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-06-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-27
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2001-07-13
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-14
FZW Expander, Surgical, Skin Graft General, Plastic Surgery Class 1 878.4800 2016-02-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2023-10-24
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2023-10-24
IQG Adaptor, Holder, Syringe Physical Medicine Class 1 890.5050 2020-01-28
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-27
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2026-03-27
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2020-09-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-09-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-09-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-27
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-12-19
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-12-19
HAB Saw, Powered, And Accessories General, Plastic Surgery Class 1 878.4820 1994-12-27
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-10-15
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-19
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-06-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-06-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-06-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2007-11-28
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2022-12-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-10-15
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-06-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-09-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-09-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-10-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-16
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-08-25
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2023-08-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-03-27
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2025-03-27
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-10-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-31
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2026-03-27
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-27
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-06-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-09-08
KQX Goniometer, Ac-Powered Orthopedic Class 1 888.1500 2020-06-19
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2025-02-03
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2025-02-03
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2009-04-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-04-16
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2012-05-11
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2012-05-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-07-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-21
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2019-10-21
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-11-17
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2022-09-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-07-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-07-16
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-27
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2011-10-17
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-01-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-01-30
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2024-01-30
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2023-04-11
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-04-11
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2025-11-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-11-19
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2025-11-19
HRX Arthroscope Orthopedic Class 2 888.1100 2010-07-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-27
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2026-03-27
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2021-09-13
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2019-05-29
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-05-06
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2025-05-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-08-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-10
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-10-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-08-11
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2026-03-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-06-17
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-06-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-07-28
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2008-11-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-12-20
HRX Arthroscope Orthopedic Class 2 888.1100 2008-07-31
HTW Bit, Drill Orthopedic Class 1 888.4540 2007-08-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2010-06-23
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2010-06-23
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2020-12-01
QHQ Total Shoulder Arthroplasty System Orthopedic Class 2 888.3660 2020-12-01
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2007-08-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2016-06-14
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-06-14
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-06-06
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2011-10-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-06
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-06
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2026-03-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-08-23
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-08-23
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-08-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-08-23
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2021-07-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-07-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2020-07-27
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-11-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-03-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2020-10-30
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2023-05-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-09-21
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2019-05-03
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2011-08-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-08-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-12-28
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2008-11-26
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2008-11-26
OSV Insufflator, Endoscopic Vessel Harvesting Obstetrics/Gynecology Class 2 884.1730 2021-09-13
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2021-09-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-06-02
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2019-12-11
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2020-12-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-08-29
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-08-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2014-02-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2026-03-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-27
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2025-03-17
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2018-07-31
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-08-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-08-29
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-12-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2007-08-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-01-23
HWQ Passer Orthopedic Class 1 888.4540 2003-08-07
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2020-06-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-07-14
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-12-05
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-12-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-04-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-04-06
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2026-03-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-12-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-12-31
PLF Bone Wedge Orthopedic Class 2 888.3030 2015-12-31
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2024-04-03
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-03-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-08-20
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2017-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-05-16
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2015-01-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-01-12
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2023-06-12
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2024-01-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-01-30
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2012-10-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-07-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-10-09
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2023-10-09
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-10-09
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-10-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-03-29
HTD Forceps General, Plastic Surgery Class 1 878.4800 2003-08-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-08-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2026-05-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-03-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-03-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2008-11-26
HXC Wrench Orthopedic Class 1 888.4540 2024-08-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-08-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-08-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-07-28
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-07-28
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-07-05
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-01-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-01-30
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2024-01-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-02-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-07-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-28
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-05-18
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-05-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-14
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2023-09-27
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2023-09-27
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2011-01-07
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2011-01-07
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-27
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-12-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-04-04
HXJ Staple Driver Orthopedic Class 1 888.4540 2008-11-26
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HRX Arthroscope Orthopedic Class 2 888.1100 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-09-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2009-09-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-03-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-03-10
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2026-03-10
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2020-12-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-01-22
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2024-01-22
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2011-10-17
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2018-06-14
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2020-03-18
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2025-01-09
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2010-09-15
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2010-09-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-03-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2011-01-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-01-31
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-04-23
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-08-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-08-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2020-11-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-11-04
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-03-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-21
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2012-01-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-01-24
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-27
HTO Reamer Orthopedic Class 1 888.4540 1994-01-27
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2023-08-03
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-05-18
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-05-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-05-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 1996-08-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-08-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-19
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2025-11-19
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2008-11-26
HRX Arthroscope Orthopedic Class 2 888.1100 2010-07-12
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2016-04-18
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2016-04-18
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2015-07-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-07-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-07-17
FXR Holder, Camera, Surgical General, Plastic Surgery Class 1 878.4160 2025-11-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-09-08
HRX Arthroscope Orthopedic Class 2 888.1100 2020-09-08
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-12-24
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-06-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-04-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-04-11
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2020-12-17
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2016-12-05
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2016-12-05
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-05-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-05-22
HWT Template Orthopedic Class 1 888.4800 2014-08-21
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2008-11-26
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2024-08-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2007-08-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-09-06
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-09-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-09-06
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2008-11-26
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2008-11-26
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2026-03-27
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-07-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-05-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-05-03
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-04-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-27
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2024-08-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-08-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-27
HXS Twister, Wire Orthopedic Class 1 888.4540 2024-08-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2011-05-27
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-02-08
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2022-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-01-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-04-24
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2023-04-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-11-18
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2017-09-28
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2024-08-29
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-09-14
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2026-03-27
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2026-03-27
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2026-03-27
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2020-08-25
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2013-12-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-09-12
FMF Syringe, Piston General Hospital Class 2 880.5860 2010-04-01
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2008-11-26
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2008-11-26
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2008-11-26
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-01-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-05-11
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-11-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-11-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-05-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-11-27
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2015-12-02
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2015-12-02
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-08-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-01-30
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-08-09
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2016-06-14
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2016-06-14
HXW Bender Orthopedic Class 1 888.4540 2025-01-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-02-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-02-10
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2014-08-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-08-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-08-20
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2017-07-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-07-28
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2019-07-26
QHQ Total Shoulder Arthroplasty System Orthopedic Class 2 888.3660 2019-07-26
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2024-07-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-07-26
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2023-12-05
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2021-09-10
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2014-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-05-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-05-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-05-18
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-05-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-05-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2007-08-23
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2007-08-23
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2025-08-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-02-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-12-31
HRX Arthroscope Orthopedic Class 2 888.1100 2008-11-26
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2012-05-15
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-05-15
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-08-06
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-08-06
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-27
QHE Shoulder Arthroplasty Implantation System Orthopedic Class 2 888.3660 2024-05-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-10-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-12-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-12-05
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2017-01-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-07-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-07
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2026-03-27
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2026-03-27
HRX Arthroscope Orthopedic Class 2 888.1100 2023-08-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-12-01
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-12-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2009-09-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2009-09-08
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-27
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2018-03-29
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-03-29
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2018-03-29
QHE Shoulder Arthroplasty Implantation System Orthopedic Class 2 888.3660 2024-10-14
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2022-09-26
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2023-08-03
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2024-08-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-08-29
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-04-03

Official Correspondent

Barry Dietz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARTHREX, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3031238646 Arthrex Medical Device (Shanghai) Co. Ltd. Shanghai, CN
3007193505 ARTHREX GMBH Odelzhausen Bavaria, DE
3013700547 Arthrex Korea Ltd. Gangnam-gu Seoul, KR
3014004349 Arthrex Singapore Pte Ltd. Singapore Central Singapore, SG
3020704423 Arthrex New Zealand Limited Auckland, NZ

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1220246. Last updated year: 2026. Please use registration number 1220246 when referencing this establishment in official correspondence.
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