FDA Registration
Active
🇫🇷 France
BIOMET FRANCE
Reg #: 3006946279
·
FEI: 3006946279
·
Expires 2026
Products
36
Proprietary Names
72
Establishment Types
2
Classifications
36
Registration Details
- Registration Name
- BIOMET FRANCE
- Registration Number
- 3006946279
- FEI Number
- 3006946279
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Plateau de Lautagne
- City
- Valence Drome
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K983853
- PMA Number
- P010014
Owner / Operator
- Firm Name
- Biomet, Inc.
- Operator Number
- 1825034
- Address
- 56 East Bell Dr., PO Box 587
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
US Agent
- Business Name
- Zimmer Biomet
- Contact Name
- Stephanie Lynch
- Address
- 1800 West Center Street
- City
- Warsaw
- State
- IN
- ZIP
- 46580
- Country
- US
- [email protected]
- Phone
- 715 9289253
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2012-06-18 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2012-06-18 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2012-06-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2012-06-18 |
| Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing | NRA | Class 3 | Unknown | No | 2006-05-19 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 1998-08-27 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2013-05-10 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1978-03-22 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2012-06-18 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2012-06-18 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2012-06-18 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2012-06-18 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2012-06-18 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1977-12-28 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2012-03-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2012-03-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2012-03-26 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2012-03-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2012-03-26 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2012-03-26 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2012-03-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2012-03-26 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2012-03-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 1977-12-28 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2003-01-08 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 1977-12-28 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 1977-12-28 |
| Template | HWT | Class 1 | Orthopedic | No | 1977-12-28 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2017-11-03 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2017-09-11 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2013-12-09 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 1977-12-28 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 1977-12-28 |
| Reamer | HTO | Class 1 | Orthopedic | No | 1978-03-24 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2013-01-27 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1992-12-08 |
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
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
INSTRUMENT
POLYAX LOCKED PLATING SYSTEM
BIOMET TEMPLATE
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
Biomet Bone Cement R
TROCHANTERIC NAIL SYSTEM
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)
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
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,
SMALL FRAGMENT LOCKING PLATING SYSTEM
ACE BROOKER BONE PLATING SYSTEM
DEPUY AE TK2 HIP SCREW SYSTEM
TAP
BIOMET BONE
BIOMET REAMER
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
ACE ORTHOPEDIC MANUFACTURING CO.
CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5
ACE HUMERUS & RADIUS PLATES
PE.R.I. II KNEE FRACTURE SYSTEM
BIOMET BONE SCREW STARTER
SURGICAL INSTRUMENT
BIOMET TRAY,
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)