FDA Registration
Active
🇺🇸 United States
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO),
Reg #: 1825034
·
FEI: 1825034
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
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
- K123907
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 |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2014-08-26 |
Proprietary Names
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO),
PRELUDE PF PATELLA COMPONENTS,
PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO),
Establishment Types
Manufacture Medical Device