Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016851379

FEI Number

3016851379

Entity Name

Arthrex Distribution Hub EMEA B.V.

City/State/Country

Venlo Limburg, NL

Establishment Address

Amperestraat 9, Venlo Limburg 5928 PE, NL

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

K151342

PMA Number

N/A

All Registered Proprietary Names

Arthrex Univers II Glenoid Components FIBERTAPE Fracture Plates & Screws knee joint patellofemorotibial polymer/metal/polymer semi-constrained Arthrex iBalance Patella Implant, Dome BI-CORTICAL BIO-POST AND WASHER BIO-ABSORBABLE CORKSCREW Arthrex iBalance BiCompartmental Arthroplasty System CONTAINER SYSTEM BIO-PIN COMPRESSION STAPLE orthopedic manual instrument Arthroscopes BIOCOMPOSITE INTERFERENCE SCREW Arthrex Knotless SutureTak Anchor OSTEOTOMY PLATE ACL TightRope FINGERSHIELD FiberTape Fiberstick FiberWire Arthrex Tibial GraftBolt CORKSCREW ANCHORS BIO-FASTAK SUTURE ANCHOR MENISCAL CINCH Arthrex Minimally Invasive Ankle Fusion Plate PROSTOP PLUS BIO-COMPRESSION SCREW Instrument, Special Lens, For Endoscope smooth or threaded metallic bone fixation fastener Arthrex FiberTak Suture Anchors orthopedic manual instrument Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories bone void filler Sutter CURIS RF Generator Laproscopes OSTEOTOMY SYSTEM Arthrex MicroSuture Anchors orthopedic manual instrument Arthrex PushLock Tenodesis Anchor Arthrex SwiveLock Anchors AESCULAP STERILCONTAINER SYSTEM Arthrex BioComposite SutureTak WASHER Single/multiple component metallic bone fixation appliances and accessories Arthrex Compression Plates FIBERWIRE BUTTON REPAIR KIT SHAVER BLADES Arthrex Low Profile Screws Stimublast COBE Angel Whole Blood Separation System OSTEOTOMY SYSTEM ARTHROSCOPY PUMP Arthrex Fracture Plates UNIVERS SHOULDER PROWICK BIO-CORKSCREW FT HATRIC CONTINUOUS WAVE III DOUBLE SYRINGE (ACP) SYSTEM display, cathode-ray tube, medical Viscogel/Viscospray Arthrex SwiveLock Anchors orthopedic manual instrument PROWICK Instrument, manual, surgical, general use ORTHOPEDIC MANUAL INSTRUMENTS TRIM-IT FAMILY Arthrex Distal Extremity Plate System Arthrex Low Profile Screws Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener Metallic Bone Fixation Biosync Bone wedge Biosync Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi UNIVERS FRACTURE Arthrex Pushlock Arthrex Univers II Shoulder Prosthesis ACCIN Uni-Knee System Clamp orthopedic manual instrument HUMERAL FRACTURE PLATE orthopedic manual instrument Component, Traction, Non-Invasive Orthopedic Template Fastener, Fixation, nondegradable, soft tissue Dressing, Compression Elastic bandage VARIOUS IMPLANTS saw blade ARTHROSCOPY LEG HOLDER Arthrex Fracture System INTERFERENCE SCREWS Table Attachments, Operating-Room orthopedic manual instrument PUSHLOCK Arthrex PCL TightRope Stimublast iBalance BIOCOMPOSITE SHAVER SYSTEM Syringe, piston Arthrex Biocomposite Transfix FiberTak DR DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER smooth or threaded metallic bone fixation fastener Adaptor, Holder, Syringe Arthrex PushLock Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System Camera Heads VARIOUS INSTRUMENTS fixation pin Arthroscope Arthrex Graft-Anchor Dual Wave Pump Syringe, Irrigating (Non Dental) RETROBUTTON INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT MINI BIO-ANCHOR WASHER Balance, Analytical Arthrex Plates, Screws, and Staples Arthrex Tibial GraftBolt ACL TightRope Double Bundle Arthrex Univers CA Heads Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis Arthrex Suture FASTAK SUTURE ANCHOR ARTHROERESIS IMPLANT Thrombinator System for use with the Arthrex Angel Concentrated Platelet Rich Plasma (PRP)System Arthroscope

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	2013-03-08
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-05-11
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2012-05-11
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-11-26
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
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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-09-08
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2020-09-08
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
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-11-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-09-01
HTN	Washer, Bolt Nut	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	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
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
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-10-15
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2020-07-27
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-08-23
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1996-08-07
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-12-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-09-24
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
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-01-14
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
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	2010-06-23
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2010-06-23
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
LZB	Finger Cot	General Hospital	Class 1	880.6250	2005-12-20
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	2007-11-28
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2010-04-13
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
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	2019-10-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-17
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
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	2019-11-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
FEI	Instrument, Special Lens, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2017-01-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-08-25
HXB	Probe	Orthopedic	Class 1	888.4540	2003-08-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-08-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-08-25
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
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
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2022-09-26
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-12-28
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2018-02-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
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
HTO	Reamer	Orthopedic	Class 1	888.4540	1994-01-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-07-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-07-05
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-09-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-09-06
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-09-03
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2014-08-25
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
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-12-20
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
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2020-12-01
QHQ	Total Shoulder Arthroplasty System	Orthopedic	Class 2	888.3660	2020-12-01
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-10-15
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-04-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-04-06
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	2019-03-29
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-05-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-05-03
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2007-08-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-11-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-12-14
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	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	2022-08-11
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	2008-11-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-11-26
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2017-12-13
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
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-09-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-04-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-04-06
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-08
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
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2020-12-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-02-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-11-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-09-12
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2017-12-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-04-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-04-11
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2020-04-09
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2024-05-23
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
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2008-11-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-03-12
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-07-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-11-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-04-16
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2023-05-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-09-21
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-12-26
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2019-12-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-18
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2017-01-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2010-04-01
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-03-29
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2003-08-07
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2009-04-16
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2007-08-23
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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-08-23
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
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	2019-12-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-12-18
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-08-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-08-26
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2018-07-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-06-02
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	2015-07-17
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-03-05
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
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-08-13
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
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
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-01-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-01-05
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2011-01-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-01-07
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2016-12-05
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2016-12-05
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2011-10-17
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2023-05-24
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-07-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-07
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-04-14
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
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1996-08-07
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
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-08-07
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	1996-08-07
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-12-31
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
HWT	Template	Orthopedic	Class 1	888.4800	2014-08-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-08-20
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2014-01-08
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
HAB	Saw, Powered, And Accessories	General, Plastic Surgery	Class 1	878.4820	1994-12-27
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2007-08-23
KQX	Goniometer, Ac-Powered	Orthopedic	Class 1	888.1500	2020-06-19
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-10-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-01-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-19
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
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-10-18
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2019-10-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-11-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-11-18
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
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-07-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-02-11
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2018-07-03
HXJ	Staple Driver	Orthopedic	Class 1	888.4540	2008-11-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-11-26
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2020-12-17
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	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
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
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2010-09-15
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2010-09-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-03-29
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-12-19
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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2017-05-30
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
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-07-17
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2017-01-24
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
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2016-12-19
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2016-12-19
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2008-11-26
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-08-23
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	2016-05-13
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2020-12-17
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-01-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-05-30
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2018-01-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-06-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-12-01
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2020-01-28
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-03-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-02-09
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-12
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2017-01-25
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2007-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-09-16
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-08-23
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2010-07-12
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-01-03
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-05-19
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2009-08-27
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2022-06-09
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-04-23
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
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
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2020-08-25
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
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	1996-08-07
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
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
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
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2019-10-18
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2007-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-11-17
JQO	Balance, Analytical	Clinical Chemistry	Class 1	862.2050	2023-08-03
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-03-23
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	2011-05-27
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2020-03-18
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
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-12-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-10-11
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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2008-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-08-23
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
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2018-06-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-11-26
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

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-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016851379. Last updated year: 2026. Please use registration number 3016851379 when referencing this establishment in official correspondence.