FDA Registration
Active
🇺🇸 United States
Rebel 3DKNEE System
Reg #: 3020745236
·
FEI: 3020745236
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- LINCOTEK MEDICAL, LLC
- Registration Number
- 3020745236
- FEI Number
- 3020745236
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 221 Commercial Parkway
- City
- Molalla
- State
- OR
- ZIP
- 97038
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143242
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
- Correspondent
- Domenico - Grieco
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2024-11-15 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-11-15 |
Proprietary Names
Rebel 3DKNEE System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)