Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015231789

FEI Number

3015231789

Entity Name

Arthrex Manufacturing Inc.

City/State/Country

Pendleton, SC, US

Establishment Address

130 Arthrex Drive, Pendleton, SC 29670, US

Establishment Type(s)

Manufacture Medical Device

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

K043145

PMA Number

N/A

All Registered Proprietary Names

Arthrex PCL TightRope Driver, Prosthesis Fastener, Fixation, nondegradable, soft tissue OSTEOTOMY SYSTEM Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener VARIOUS IMPLANTS SHOULDER HOLDER Apparatus, Traction, Non-Powered SHAVER SYSTEM ORTHOPEDIC MANUAL INSTRUMENTS BIO-FASTAK SUTURE ANCHOR Arthrex Biocomposite Transfix INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT drill bit MINI BIO-ANCHOR SHAVER BLADES BIOCOMPOSITE SUTURE ANCHORS smooth or threaded metallic bone fixation fastener DOUBLE SYRINGE (ACP) SYSTEM Arthrex iBalance BiCompartmental Arthroplasty System AOS HUMERAL NAI Arthrex Fracture System FASTAK SUTURE ANCHOR General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure Arthrex Distal Extremity Plate System ACCIN Uni-Knee System Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories Source, Carrier, Fiberoptic Light orthopedic manual instrument orthopedic manual instrument BIO-ABSORBABLE CORKSCREW INTERFERENCE SCREW MINI TIGHTROPE BIO-CORKSCREW FT OSTEOTOMY SYSTEM WASHER VARIOUS INSTRUMENTS Dual Wave Pump Bio-Composite SutureTak CONTINUOUS WAVE III FiberTak DR Catheter, Irrigation Arthrex BioSuture Nonabsorbable poly(ethylene terephthalate) Surgical Suture Arthrex Suture TRIM-IT FAMILY ACCIN Patellofemoral System CORKSCREW ANCHORS Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi Pliers, Surgical CONTAINER SYSTEM Instrument, manual, surgical, general use BIO-POST AND WASHER ARTHROERESIS IMPLANT BIOCOMPOSITE INTERFERENCE SCREW PUSHLOCK Mini TightRope CMC Arthrex Tibial GraftBolt Stimublast fixation plate Single/multiple component metallic bone fixation appliances and accessories Arthrex Ankle Fusion Plating System ACL TightRope FIBERWIRE BUTTON REPAIR KIT Arthrex iBalance TKA System Knee Joint Patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis smooth or threaded metallic bone fixation fastener Arthrex FiberTak Suture Anchors VARIOUS BURS Arthrex PushLock Drape, Surgical, Exempt TAK FAMILY OPES ELECTRODES AND ACCESSORIES RF device, blade, hook WASHER Arthrex PushLock Tenodesis Anchor MENISCAL CINCH AESCULAP STERILCONTAINER SYSTEM Arthrex SwiveLock Anchors Orthopedic Template BIO-COMPRESSION SCREW Arthrex Fracture Plates Arthrex BioComposite SutureTak BIOCOMPOSITE ACCIN Uni-Knee System fixation plate LOW PROFILE PLATE AND SCREW SYSTEM Holder, Camera, Surgical bone void filler orthopedic manual instrument TENODESIS FAMILY Mallet HUMERAL FRACTURE PLATE Arthrex Fracture System Single/multiple component metallic bone fixation appliances and accessories Arthrex Compression Plates Balance, Analytical Arthrex Low Profile Screws COMPRESSION STAPLE Arthrex Univers CA Heads Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis BIO-PIN orthopedic manual instrument OSTEOTOMY PLATE Arthrex Graft-Anchor BI-CORTICAL BIO-POST AND WASHER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-05-19
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
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2024-08-29
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
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	2013-08-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
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
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-07-17
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2008-11-26
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2007-08-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-09-09
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-04-04
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-03-23
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2008-11-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-04-05
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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-08-23
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	2018-08-20
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-09-16
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
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	2019-12-26
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2017-01-24
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2020-04-09
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
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	1996-08-07
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2007-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-07-21
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-09-12
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2026-03-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-03-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-01-23
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
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	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
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
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
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-06-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-04-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-12-31
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
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2017-12-18
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-06-06
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
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-10-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-09-01
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-05
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	2016-06-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-06-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2008-11-26
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2021-08-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-08-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-08-26
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2011-10-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-08-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-08-25
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2024-08-29
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-08-11
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
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2020-03-18
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
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2022-12-21
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1996-08-07
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
HXJ	Staple Driver	Orthopedic	Class 1	888.4540	2008-11-26
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
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2008-11-26
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2019-05-03
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-07-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
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
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
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-28
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
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2007-08-23
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2018-02-27
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	2025-03-27
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2025-03-27
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2007-08-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-04-23
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-07-27
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2009-08-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-22
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
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
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-11-19
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-07-31
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-05-13
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2023-12-05
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2014-02-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-10-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-01-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-14
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-06-29
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-11-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-11-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-12
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
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2011-10-17
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2022-06-09
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-11-20
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-17
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-06-17
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
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-08-29
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-10-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-09-28
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	2025-03-17
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2007-08-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2026-05-29
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	2018-06-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-06-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	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
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-12-07
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2009-12-07
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	2018-05-18
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-05-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2010-04-13
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2025-01-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-18
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
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
HRS	Plate, Fixation, Bone	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	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	2023-08-09
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
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-03-23
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2024-10-14
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
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	2017-09-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-09-05
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-12-24
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-08-25
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2007-08-23
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-07-28
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-03-28
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
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2024-03-28
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	2024-10-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-11-26
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2007-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-02-13
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-09-06
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
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-07-18
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-05-20
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
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	2022-08-29
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-08-29
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-02-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-02-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-01
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
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-10-15
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
HWT	Template	Orthopedic	Class 1	888.4800	2014-08-21
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-09-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-11-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-04-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-04-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-04-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-04-11
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
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
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-02
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
FXR	Holder, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2025-11-19
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2008-11-26
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2003-08-07
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
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
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2024-08-29
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
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
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	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
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-12-05
JQO	Balance, Analytical	Clinical Chemistry	Class 1	862.2050	2023-08-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2017-05-30
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-05-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-04-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-04-06
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-07-05
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
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
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-12-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-09-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-09-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-09-04
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
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
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-08-23
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2001-07-13
HRS	Plate, Fixation, Bone	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	2013-07-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-16
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-05-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-04-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-03-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-01-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-01-05
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2007-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23

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
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
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.

Similar Registrations

Registration Number	Establishment Name	Location
1219930	Covidien	North Haven, CT, US
3016660811	SUBCHONDRAL SOLUTIONS	Costa Mesa, CA, US
1054811	Sterigenics U.S. LLC	MULBERRY, FL, US
3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
3011989923	DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI	Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015231789. Last updated year: 2026. Please use registration number 3015231789 when referencing this establishment in official correspondence.