FDA Registration
Active
🇺🇸 United States
Exeter IM Plug
Reg #: 2249697
·
FEI: 3003070421
·
Expires 2025
Products
4
Proprietary Names
5
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- HOWMEDICA OSTEONICS CORP
- Registration Number
- 2249697
- FEI Number
- 3003070421
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 325 CORPORATE DR.
- City
- MAHWAH
- State
- NJ
- ZIP
- 07430
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173499
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2018-03-23 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2018-03-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-03-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2018-03-23 |
Proprietary Names
Exeter IM Plug
Exeter Related Instrumentation
UHR Bipolar Femoral Heads
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
Unitrax Modular Endo Heads
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device