FDA Registration
Active
🇺🇸 United States
Cement Restrictor
Reg #: 1818910
·
FEI: 1818910
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
4
Classifications
1
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
- K800894
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, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 1984-02-15 |
Proprietary Names
Cement Restrictor
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only
Repack or Relabel Medical Device
Manufacture Medical Device