FDA Registration
Active
🇺🇸 United States
Shoulder Replacement Device
Reg #: 3004464325
·
FEI: 3004464325
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DEPUY ORTHOPAEDICS
- Registration Number
- 3004464325
- FEI Number
- 3004464325
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 50 SCOTLAND BLVD.
- City
- BRIDGEWATER
- State
- MA
- ZIP
- 02324
- Country
- US
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, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2017-05-04 |
Proprietary Names
Shoulder Replacement Device
Establishment Types
Manufacture Device in the United States for Export Only