Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002579136

FEI Number

3002579136

Entity Name

Arthrex GmbH

City/State/Country

Munich Bavaria, DE

Establishment Address

Erwin-Hielscher-Strasse 9, Munich Bavaria 81249, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

K173845

PMA Number

N/A

All Registered Proprietary Names

MENISCAL CINCH VARIOUS INSTRUMENTS TENODESIS FAMILY Camera Heads ANATOEMIC PROSTHESIS ARTHREX ANATOEMIC P Laproscopes Arthroscopes Orthopedic Template Dual Wave Pump orthopedic manual instrument SHAVER BLADES UNIVERS FRACTURE Fastener, Fixation, nondegradable, soft tissue BIO-COMPRESSION SCREW Arthrex Low Profile Screws Univers II Arthrex BioComposite SutureTak FiberStitch Implant SHAVER SYSTEM Arthrex Fracture Plates Mini TightRope CMC Clamp DOUBLE SYRINGE (ACP) SYSTEM Arthrex Univers Apex Shoulder joint metal/ polymer semi-constrained cemented prosthesis INTERFERENCE SCREWS Instrument, Special Lens, For Endoscope INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT BIOCOMPOSITE SUTURE ANCHORS Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System Balance, Analytical Arthrex Plates, Screws, and Staples Single/multiple component metallic bone fixation appliances and accessories Arthrex Ankle Fusion Plating System Bio-Composite SutureTak CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO Arthroscope Arthrex SwiveLock Anchors Fracture Plates & Screws SHOULDER HOLDER Apparatus, Traction, Non-Powered Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi ARTHROSCOPY PUMP TAK FAMILY UNIVERS SHOULDER Syringe, piston BIO-ABSORBABLE CORKSCREW HUMERAL FRACTURE PLATE fixation pin ORTHOPEDIC MANUAL INSTRUMENTS BIO-CORKSCREW FT Camera, Television, Surgical, Without Audio PUSHLOCK saw blade FiberTape Fiberstick FiberWire fixation plate LOW PROFILE PLATE AND SCREW SYSTEM Arthrex PushLock BI-CORTICAL BIO-POST AND WASHER drill bit display, cathode-ray tube, medical Orthopedic manual surgical instrument, Passer BIO-PIN Component, Traction, Non-Invasive CORKSCREW ANCHORS Arthrex iBalance BiCompartmental Arthroplasty System Arthrex MicroSuture Anchors CONTAINER SYSTEM Arthrex Biocomposite Transfix

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	2023-11-20
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
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-09-24
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
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	2008-11-26
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2007-08-23
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2019-10-10
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
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2017-01-25
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2007-01-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-12-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-12-28
HWT	Template	Orthopedic	Class 1	888.4800	2014-08-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-10
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2009-08-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-05-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-09-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-09-05
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2003-08-07
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2007-08-23
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-05-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-05-03
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	2013-08-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-04-13
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
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
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-11-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-11-18
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2022-09-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-09-13
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2008-11-26
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2013-06-24
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-06-24
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	2013-04-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-04-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-11-27
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	2024-05-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-12-07
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2009-12-07
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2023-05-24
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-04-16
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	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
FEI	Instrument, Special Lens, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2017-01-25
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-09-03
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	1996-08-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-05-31
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
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-08-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-08-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-11-17
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-02-09
JQO	Balance, Analytical	Clinical Chemistry	Class 1	862.2050	2023-08-03
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-09-21
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
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
FWL	Camera, Cine, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	1994-01-27
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	2015-05-18
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2015-05-18
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-02-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-02-10
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
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
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
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2010-07-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-09-04
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-12-01
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
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
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
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2007-08-23
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
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2018-02-27
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-11-26
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
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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2020-07-27
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-01-03
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-12-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-08-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-12-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
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	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
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
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	2020-12-01
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2020-12-01
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2020-12-17
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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2017-05-30
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
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-06-15
HAB	Saw, Powered, And Accessories	General, Plastic Surgery	Class 1	878.4820	1994-12-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-09-28
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2007-11-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-03-28
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2007-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-09-12
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2007-08-23
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2023-05-22
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-18
HWQ	Passer	Orthopedic	Class 1	888.4540	2003-08-07
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-08-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-09-14
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	1996-08-07
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-08-23
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2016-02-25
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
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
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2017-12-13
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-10-15
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-08-20

Official Correspondent

Barry Dietz

US Agent Details

Barry Dietz Business: Arthrex Inc Email: Regulatory_Affairs@Arthrex.com Phone: (800) 9337001

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-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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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 3002579136. Last updated year: 2026. Please use registration number 3002579136 when referencing this establishment in official correspondence.