BIOMET FRANCE

FDA Device Registration & Listing · Valence Drome, FR · Registration 3006946279

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

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006946279
FEI Number
3006946279
Entity Name
BIOMET FRANCE
City/State/Country
Valence Drome, FR
Establishment Address
Plateau de Lautagne, Valence Drome 26000, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Biomet, Inc. (Owner Number: 1825034)
Owner / Operator Contact Address
56 East Bell Dr., PO Box 587, Warsaw, IN 46582, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K100238
PMA Number
N/A

All Registered Proprietary Names

DEPUY ACE TIMAX META PLATE SMALL BONE LOCKING PLATING SYSTEM ACE OPEN-BACK HALO RING Biomet Proximal Humerus Plating System ACE AIM TTC FUSION NAIL TWIST-OFF SCREW ACE 3.5MM CORTICAL BONE SCREW LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM OXFORD MENISCAL UNICOM GUIDE BIOMET SURGICIAL ENDOBON XENOGRAFT GRANULES MULTIPLICITY OF PRODUCTS STAPLE FIXATION, BONE; SCREW FIXATION BONE MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE SCREWDRIVER BIOMET ACE CANCELLOUS BONE SCREW TRAUMA INTERNAL FIXATION SYSTEMS RETRACTOR BIOMET ARCOS INTERLOCKING DISTAL STEMS ACE RECONSTRUCTIVE PLATE ZINDRICK IM ROD BIOMET DRILL BIT BIOMET GENERAL ORTHOPEDIC MANUAL INSTRUMENT HOLDING FORCEPS BIOMET WIRE BENDING AND CONTOURING BIOMET INSTRUMENT POLYAX LOCKED PLATING SYSTEM BIOMET TEMPLATE ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM Biomet Bone Cement R TROCHANTERIC NAIL SYSTEM ACE CANCELLOUS BONE SCREW UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW Refobacin Bone Cement R BIOMET CEMENT DISPENSER TWIST-OFF (TM) SCREW 6.5MM SOLID CANCELLOUS BONE SCREW Refobacin Bone Cement R (110034355) Refobacin Bone Cement R ACE CORTICAL BONE SCREW DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL FRS SCREW ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW A. L. P. S. Clavicle Plating System ANATOMIC LOCKING PLATING SYSTEM SURGICAL PLIERS Zimmer BIOMET 824677021, 22, 824071001, 824071101, 824671001, 82467 CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021 HFN RH 125 DEGREE 9-13MM HFN 125 DEG 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM,

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-06-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-06-18
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2012-06-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-04-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-06-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-07-10
NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown Class 3 N/A 2006-05-19
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1998-08-27
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2013-05-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-06-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-06-18
HXX Screwdriver Orthopedic Class 1 888.4540 1978-03-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-06-18
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-06-18
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2012-06-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-06-18
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2012-06-18
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2012-06-18
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2012-06-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-18
GAD Retractor General, Plastic Surgery Class 1 878.4800 1977-12-28
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2012-03-26
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2012-03-26
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2012-03-26
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2012-03-26
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2012-03-26
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2012-03-26
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2012-03-26
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-03-26
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2012-03-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-06-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-06-17
HTW Bit, Drill Orthopedic Class 1 888.4540 1977-12-28
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2003-01-08
HYA Forceps, Wire Holding General, Plastic Surgery Class 1 878.4800 1977-12-28
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 1977-12-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-06-18
HWT Template Orthopedic Class 1 888.4800 1977-12-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-06-18
LOD Bone Cement Orthopedic Class 2 888.3027 2017-11-03
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-06-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-06-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-18
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2017-09-11
LOD Bone Cement Orthopedic Class 2 888.3027 2017-09-11
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2013-12-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-18
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2026-06-11
LOD Bone Cement Orthopedic Class 2 888.3027 2026-06-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-17
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-06-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-01-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-06-18
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2012-06-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-06-18
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 1977-12-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-06-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-06-18

Official Correspondent

No official correspondent registered.

US Agent Details

Stephanie Lynch Business: Zimmer Biomet Email: Stephanie.Lynch@zimmerbiomet.com Phone: (715) 9289253

Related Public Records

Same Entity

Biomet, 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
1216032 Citra Labs LLC Braintree, MA, US
1825034 BIOMET, INC. WARSAW, IN, US
3006801265 Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang, CN
3002806535 BIOMET UK LTD. BRIDGEND, GB
3007923096 Changzhou Biomet Medical Devices Co., Ltd. Changzhou City Jiangsu, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K983036 Biomet, Inc. SINGLE AXLE TOTAL ELBOW 1999-04-30
K950761 Biomet, Inc. INDEX ACETABULAT COMPONENT 1995-05-02
K031454 Biomet, Inc. ACUMEN SURGICAL NAVIGATION SYSTEM 2004-07-08
K921181 Biomet, Inc. MALLORY-HEAD TOTAL HIP SYSTEM 1994-02-16
K830313 Biomet, Inc. CFE TOTAL HIP FEMORAL COMPONENT 1983-05-25

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-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0032-2009 Biomet, Inc. 2
Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.
Z-0033-2009 Biomet, Inc. 2
Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006946279. Last updated year: 2026. Please use registration number 3006946279 when referencing this establishment in official correspondence.
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