FDA Registration
Active
🇺🇸 United States
Insignia Hip Stem
Reg #: 2249697
·
FEI: 3003070421
·
Expires 2025
Products
8
Proprietary Names
2
Establishment Types
2
Classifications
8
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
- K211703
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, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2021-08-24 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2021-08-24 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2021-08-24 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-08-24 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-08-24 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-08-24 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2021-08-24 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-08-24 |
Proprietary Names
Insignia Hip Stem
Insignia Instruments
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device