FDA Registration
Active
🇺🇸 United States
Trident II Tritanium Acetabular Cup System and 6.5mm Low Profile Hex Screws (Solidback, Clusterhole and Multihole)
Reg #: 2249697
·
FEI: 3003070421
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
2
Classifications
5
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
- K161569
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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2016-10-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2016-10-17 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2016-10-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2016-10-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2016-10-17 |
Proprietary Names
Trident II Tritanium Acetabular Cup System and 6.5mm Low Profile Hex Screws (Solidback, Clusterhole and Multihole)
Stryker Orthopaedics Instruments
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device