FDA Registration
Active
🇺🇸 United States
Zimmer NexGen Tibial and Femoral Augments LCCK FEM PROV/CUT GUIDE SIZE G L (00-5995-017-01)
Reg #: 3010039400
·
FEI: 3010039400
·
Expires 2025
Products
2
Proprietary Names
2
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- Lincotek Medical LLC
- Registration Number
- 3010039400
- FEI Number
- 3010039400
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 811 Northwoods Blvd
- City
- Vandalia
- State
- OH
- ZIP
- 45377
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152494
Owner / Operator
- Firm Name
- Lincotek Medical, LLC
- Operator Number
- 9057128
- Address
- 3110 Stage Post Dr., Suite 117
- City
- Bartlett
- State
- TN
- Postal Code
- 38133
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-08-17 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2018-08-17 |
Proprietary Names
Zimmer NexGen Tibial and Femoral Augments LCCK FEM PROV/CUT GUIDE SIZE G L (00-5995-017-01)
Zimmer NexGen Tibial and Femoral Augments LCCK FEM PROV/CUT GUIDE SIZE G R (00-5995-017-02)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)