FDA Registration
Active
🇺🇸 United States
BIOMET MODULAR FEMORAL REVISION SYSTEM
Reg #: 1828464
·
FEI: 1828464
·
Expires 2025
Products
9
Proprietary Names
2
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- SYMMETRY MEDICAL MANUFACTURING INC.
- Registration Number
- 1828464
- FEI Number
- 1828464
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 486 West 350 North
- City
- WARSAW
- State
- IN
- ZIP
- 46582
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090757
Owner / Operator
- Firm Name
- Tecomet
- Operator Number
- 1828464
- Address
- 170 New Boston Street, --
- City
- Woburn
- State
- MA
- Postal Code
- 01801
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-02-15 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2013-02-15 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2013-02-15 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2013-02-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2013-02-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2013-02-15 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-02-15 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2013-02-15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-02-15 |
Proprietary Names
BIOMET MODULAR FEMORAL REVISION SYSTEM
prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)