FDA Registration
Active
🇺🇸 United States
LPS, Orthogenesis
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
- K011810
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, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2004-02-02 |
Proprietary Names
LPS, Orthogenesis
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only
Manufacture Medical Device