Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010331645

FEI Number

3010331645

Entity Name

Arthrex, Inc.

City/State/Country

Ave Maria, FL, US

Establishment Address

6875 Arthrex Commerce Drive, Ave Maria, FL 34142, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

ARTHREX, INC. (Owner Number: 1220287)

Owner / Operator Contact Address

1370 CREEKSIDE BLVD., --, Naples, FL 34108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PARS Needle PUSHLOCK orthopedic manual instrument WASHER Arthrex Biocomposite Transfix SHAVER BLADES ARTHROSCOPY LEG HOLDER Wrench Arthrex Low Profile Screws orthopedic manual instrument Orthopedic manual surgical instrument, Passer Source, Carrier, Fiberoptic Light ORTHOPEDIC MANUAL INSTRUMENTS UNIVERS SHOULDER Forceps, General & Plastic Surgery orthopedic manual instrument Arthrex Fracture System Arthrex MicroSuture Anchors BIO-BUTTON Pliers, Surgical TWISTER, WIRE Clamp SHAVER SYSTEM Fracture Plates & Screws Arthrex Tibial GraftBolt Mallet ACL TightRope Mini TightRope CMC ACCIN Patellofemoral System Instrument, Special Lens, For Endoscope Arthrex Plates, Screws, and Staples Arthrex SwiveLock Anchors Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi Arthrex Fracture Plates CONTINUOUS WAVE III FiberTak DR Arthrex BioComposite SutureTak Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System AOS HUMERAL NAI single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes ACL TightRope Double Bundle Arthrex SwiveLock Anchors BIOCOMPOSITE INTERFERENCE SCREW orthopedic manual instrument CONTAINER SYSTEM BENDER bone void filler Stimublast BIO-COMPRESSION SCREW FIBERTAPE Instrument, manual, surgical, general use ARTHROSCOPY LEG HOLDER BIO-ABSORBABLE CORKSCREW Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener DOUBLE SYRINGE (ACP) SYSTEM Arthrex BioSuture Nonabsorbable poly(ethylene terephthalate) Surgical Suture UNIVERS II Single/multiple component metallic bone fixation appliances and accessories Arthrex Compression Plates OSTEOTOMY SYSTEM Camera Heads BIO-FASTAK SUTURE ANCHOR Arthrex Suture smooth or threaded metallic bone fixation fastener BIO-CORKSCREW FT WASHER orthopedic manual instrument Dual Wave Pump Arthrex Tibial GraftBolt CORKSCREW ANCHORS Arthrex Graft-Anchor SUPPORT, PATIENT POSITION ARTHROSCOPY PUMP Component, Traction, Non-Invasive Syringe, piston RETROBUTTON BIOCOMPOSITE Arthrex Small External Fixation System ARTHROERESIS IMPLANT Table Attachments, Operating-Room ACCIN Uni-Knee System Orthopedic Template Univers II BIO-PIN fixation pin INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Arthroscopes OSTEOTOMY SYSTEM 40 L HIGH FLOW INSUFFLATOR F108 FIBERWIRE BUTTON REPAIR KIT PROSTOP PLUS MENISCAL CINCH Arthrex SwiveLock Anchors Metallic Bone Fixation Biosync Bone wedge Biosync iBalance Arthrex PCL TightRope Accessories, Photographic, For Endoscope (Exclude Light Sources) MENISCAL DART, DARTSTICK, CHONDRAL DART MINI TIGHTROPE BIO-POST AND WASHER BIOCOMPOSITE SUTURE ANCHORS Laproscopes Catheter, Irrigation Dressing, Compression Elastic bandage orthopedic manual instrument Holder, Camera, Surgical Arthrex PushLock Tenodesis Anchor Arthrex Knotless SutureTak Anchor DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER FINGERSHIELD Arthroscope Arthrex Pushlock FASTAK SUTURE ANCHOR ACCIN Uni-Knee System HUMERAL FRACTURE PLATE OPES ELECTRODES AND ACCESSORIES RF device, blade, hook Camera, Television, Surgical, Without Audio TENODESIS FAMILY Driver, Prosthesis cart, emergency, cardiopulmonary INTERFERENCE SCREWS ACCIN Total Knee System knee joint patellofemorotibial polymer/metal/polymer semi-constrained Arthrex iBalance Patella Implant, Dome Fastener, Fixation, nondegradable, soft tissue Arthrex Fracture System Arthrex Minimally Invasive Ankle Fusion Plate Arthrex PushLock VARIOUS BURS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-03-23
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	1994-01-27
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
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1996-08-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-18
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2007-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-04-13
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
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2007-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-12-19
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2007-08-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-03-09
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-03-09
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2023-03-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-03-09
HXC	Wrench	Orthopedic	Class 1	888.4540	2024-08-29
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2017-01-24
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2015-05-18
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2015-05-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-01-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-03-27
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2025-03-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-06-14
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-08-07
HWQ	Passer	Orthopedic	Class 1	888.4540	2003-08-07
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2025-04-10
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2025-04-10
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	2019-10-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2017-05-30
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
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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-11-01
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2024-08-29
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-08-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-01-14
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-05-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-05-03
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-09-07
HTO	Reamer	Orthopedic	Class 1	888.4540	1994-01-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-09-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-01-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-19
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
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2019-10-10
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
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
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
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-08-29
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2024-08-29
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2023-05-24
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-10-22
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-11-19
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2011-05-27
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2024-08-29
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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-12-07
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2009-12-07
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2011-10-17
FEI	Instrument, Special Lens, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2017-01-25
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-07-28
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2025-01-14
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-08-30
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	2013-04-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-04-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-07-31
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-05-13
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	2011-04-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-04-06
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-02-09
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-10-15
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2014-03-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-07
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2019-05-03
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-07-28
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
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
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-08-13
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
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2018-02-27
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
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
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2008-11-26
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2024-04-26
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2026-03-26
HXB	Probe	Orthopedic	Class 1	888.4540	2003-08-07
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-11-27
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-10-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-09-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-09-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-07-21
HXW	Bender	Orthopedic	Class 1	888.4540	2025-01-09
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-07-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-29
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2013-12-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-12-23
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-07-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-07-14
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-07-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-11-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-02-11
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2007-08-23
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	2008-11-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2008-11-26
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2008-11-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-07-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2022-12-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-28
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-04-16
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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2014-02-26
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-12-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2016-04-27
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2016-04-27
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2017-01-25
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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-10-11
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
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2020-07-09
QHQ	Total Shoulder Arthroplasty System	Orthopedic	Class 2	888.3660	2020-07-09
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-06-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-09-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-09-04
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-06-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2026-05-29
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-11-26
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2007-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-12-31
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2003-08-07
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2009-08-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-08-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2010-04-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-17
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-06-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-09-21
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2020-03-18
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-10-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-10-18
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2007-08-23
JDR	Staple, Fixation, Bone	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
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
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
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2023-06-12
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-03-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-11-26
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	1996-08-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-08-23
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
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-18
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-09-16
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
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	2007-08-23
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2018-07-03
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	2018-03-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-09-08
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2020-09-08
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
HWT	Template	Orthopedic	Class 1	888.4800	2014-08-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-08-05
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
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-11-03
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-11-03
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-08-23
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2017-12-13
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-08-23
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	1996-08-07
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
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-12-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-05-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-01-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-05-11
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2018-07-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-12-23
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2013-12-23
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
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
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	2008-11-26
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
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
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	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
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-03-29
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
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2019-10-18
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-05-29
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-09-01
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-07-28
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2020-10-30
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-11-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-03-01
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2021-09-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-08
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2009-04-16
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2009-04-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-08-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-01-13
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-04-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-01-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2008-11-26
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-09-28
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
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
MNU	Staple, Absorbable	Orthopedic	Class 2	888.3030	2008-11-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-12-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-12-31
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
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2023-12-05
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
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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2020-07-27
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-04-05
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
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2024-04-03
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
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2014-01-08
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1996-08-07
FXR	Holder, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2025-11-19
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-07-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-06-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-06-30
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-09-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-10-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-10-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-10-26
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2024-10-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-01-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-03-23
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2025-05-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-05-23
LZB	Finger Cot	General Hospital	Class 1	880.6250	2005-12-20
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
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2010-07-12
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2008-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-06-02
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2021-09-13
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2022-09-26
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2011-10-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-05-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-11-07
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-06-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-06-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-07-05
FWB	Camera, Television, Surgical, Without Audio	General, Plastic Surgery	Class 1	878.4160	2024-07-25
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-16
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2024-08-29
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-03-08
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
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2025-01-09
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-09-03
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-11-20
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-05-30
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-05-30
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
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2026-03-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-03-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-10-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-11-26
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2024-02-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-31
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-08-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-05-01
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-16
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2012-01-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-01-16
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-09-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-17
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-06-15
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-03-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-18
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2025-11-19
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2025-11-19
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
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2007-08-23
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

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
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K203334	Acuitive Technologies, Inc.	The Citrefix Knotless Suture Anchor	2021-02-05
K243467	Osteonic Co., Ltd.	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	2024-12-03
K213415	OSSIO , Ltd.	OSSIOfiber Suture Anchor	2022-03-28
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23

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 3010331645. Last updated year: 2026. Please use registration number 3010331645 when referencing this establishment in official correspondence.