FDA Registration
Active
🇺🇸 United States
TRAUMA INTERNAL FIXATION SYSTEMS
Reg #: 1825034
·
FEI: 1825034
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- BIOMET, INC.
- Registration Number
- 1825034
- FEI Number
- 1825034
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 56 E Bell Dr, Po Box 587
- City
- WARSAW
- State
- IN
- ZIP
- 46581
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111663
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
- Correspondent
- Kevin W Escapule
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2012-06-18 |
| 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, Metal Composite | LXT | Class 2 | Orthopedic | No | 2012-06-18 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2012-06-18 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2012-06-18 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2012-06-18 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2012-06-18 |
Proprietary Names
TRAUMA INTERNAL FIXATION SYSTEMS
Establishment Types
Manufacture Medical Device