FDA Registration
Active
🇺🇸 United States
Stryker Mako
Reg #: 3003387384
·
FEI: 3003387384
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- Phillips Precision Inc
- Registration Number
- 3003387384
- FEI Number
- 3003387384
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7 Paul Kohner Pl
- City
- Elmwood Park
- State
- NJ
- ZIP
- 07407
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133811
Owner / Operator
- Firm Name
- Phillips Precision Inc/Creighton
- Operator Number
- 10042522
- Address
- 7 Paul Kohner Place
- City
- Elmwood Park
- State
- NJ
- Postal Code
- 07407
- Country
- US
- Correspondent
- Shalyn Creighton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | NJD | Class 2 | Orthopedic | No | 2015-05-15 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2015-05-15 |
Proprietary Names
Stryker Mako
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)