FDA Registration
Active
🇺🇸 United States
Stryker - Triathlon Instruments Patella Clamp (6541-3-600) (1001879)
Reg #: 3003639920
·
FEI: 3003639920
·
Expires 2025
Products
6
Proprietary Names
3
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- OBERG MEDICAL PRODUCTS COMPANY
- Registration Number
- 3003639920
- FEI Number
- 3003639920
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 273 N Pike Rd
- City
- Sarver
- State
- PA
- ZIP
- 16055
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172326
Owner / Operator
- Firm Name
- Oberg Industries LLC
- Operator Number
- 9047380
- Address
- 273 North Pike Road
- City
- Sarver
- State
- PA
- Postal Code
- 16055
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2021-03-25 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2021-03-25 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2021-03-25 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2021-03-25 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2021-03-25 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-03-25 |
Proprietary Names
Stryker - Triathlon Instruments Patella Clamp (6541-3-600) (1001879)
Stryker - Triathlon Instruments Patella Stylus (6541-3-601) (1001880)
Stryker - Triathlon Instruments Distal Capture Assembly (6541-1-723) (1000056)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)