FDA Registration
Active
🇺🇸 United States
S-Rom, Noiles (knee)
Reg #: 1219655
·
FEI: 1219655
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DEPUY ORTHOPAEDICS, INC.
- Registration Number
- 1219655
- FEI Number
- 1219655
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 325 PARAMOUNT DR.
- City
- RAYNHAM
- State
- MA
- ZIP
- 02767
- Country
- US
Regulatory Submissions
- 510(k) Number
- K924940
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, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2011-08-24 |
Proprietary Names
S-Rom, Noiles (knee)
Establishment Types
Manufacture Medical Device