FDA Registration
Active
🇺🇸 United States
Lincotek Medical
Reg #: 3008421730
·
FEI: 3008421730
·
Expires 2026
Products
10
Proprietary Names
17
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Lincotek Medical
- Registration Number
- 3008421730
- FEI Number
- 3008421730
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3110 Stage Post Dr Ste 117
- City
- Bartlett
- State
- TN
- ZIP
- 38133
- Country
- US
Owner / Operator
- Firm Name
- Surface Dynamics LLC
- Operator Number
- 10047928
- Address
- 3110 Stage Post Dr Ste 101
- City
- Bartlett
- State
- TN
- Postal Code
- 38133
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2019-08-02 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2019-03-11 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2019-08-02 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2014-11-17 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2016-05-16 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2019-08-12 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2018-02-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-03-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-03-11 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-08-12 |
Proprietary Names
AVL HINGE KNEE SYSTEM
M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
In Bone
RINGLOC + HYBRID ACETABULAR SYSTEM
ONCOLOGY SALVAGE SYSTEM
POROUS COATED ACETABULAR COMPONENTS
POROUS COATED COMPREHENSIVE FRACTURE STEMS
ORTHOPEDIC SALVAGE SYSTEM - OSS
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
M2A MAGNUM SYSTEM
Comprehensive Primary Stem
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM)
MALLORY- HEAD TOTAL HIP SYSTEM
Comprehensive Shoulder System
MALLORY/HEAD TOTAL HIP SYSTEM
BIOMET KNEE JOINT REPLACEMENT PROSTHESES
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)