FDA Registration
Active
🇺🇸 United States
COMPREHENSIVE CONVERTIBLE GLENOID
Reg #: 1825034
·
FEI: 1825034
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
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
- K130390
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, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2013-11-22 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2013-11-22 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2013-11-22 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2013-11-22 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2013-11-22 |
Proprietary Names
COMPREHENSIVE CONVERTIBLE GLENOID
Establishment Types
Manufacture Medical Device