FDA Registration
Active
🇺🇸 United States
Summit Hip System
Reg #: 1818910
·
FEI: 1818910
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- DEPUY ORTHOPAEDICS, INC.
- Registration Number
- 1818910
- FEI Number
- 1818910
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 700 ORTHOPAEDIC DR.
- City
- WARSAW
- State
- IN
- ZIP
- 46582
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170339
Owner / Operator
- Firm Name
- DePuy Synthes, Inc.
- Operator Number
- 1818910
- Address
- 700 Orthopaedic Drive
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2018-07-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2018-07-11 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2018-07-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2018-07-11 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2018-07-11 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2018-07-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-07-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2018-07-11 |
Proprietary Names
Summit Hip System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device