FDA Registration
Active
🇺🇸 United States
BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR
Reg #: 1825034
·
FEI: 1825034
·
Expires 2025
Products
8
Proprietary Names
2
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
- K073102
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, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2009-03-17 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2009-03-17 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2009-03-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2009-03-17 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2009-03-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2009-03-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2009-03-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2009-03-17 |
Proprietary Names
BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR
LINERS
Establishment Types
Manufacture Medical Device