FDA Registration
Active
🇺🇸 United States
NEXGEN COMPLETE KNEE SOLUTION TIBIAL BOOM 7 DEGREE
Reg #: 3004513872
·
FEI: 3004513872
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- FIVE STAR MANUFACTURING, INC.
- Registration Number
- 3004513872
- FEI Number
- 3004513872
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 163 SAMUEL BARNET BLVD.
- City
- NEW BEDFORD
- State
- MA
- ZIP
- 02745
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152494
Owner / Operator
- Firm Name
- FIVE STAR MANUFACTURING, INC.
- Operator Number
- 9061981
- Address
- 163 SAMUEL BARNET BLVD., --
- City
- New Bedford
- State
- MA
- Postal Code
- 02745
- Country
- US
- Correspondent
- DAVID A CABRAL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2019-03-08 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-03-08 |
Proprietary Names
NEXGEN COMPLETE KNEE SOLUTION TIBIAL BOOM 7 DEGREE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)