FDA Registration
Active
🇺🇸 United States
Optimotion Implants Porous Metal-Backed Patella
Reg #: 3016470314
·
FEI: 3016470314
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- OPTIMOTION IMPLANTS, LLC
- Registration Number
- 3016470314
- FEI Number
- 3016470314
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6052 Turkey Lake Road, Suite 170
- City
- Orlando
- State
- FL
- ZIP
- 32819
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220049
Owner / Operator
- Firm Name
- Optimotion
- Operator Number
- 10074026
- Address
- 6052 Turkey Lake Road, Suite 170
- City
- Orlando
- State
- FL
- Postal Code
- 32819
- Country
- US
- Correspondent
- Andy Rynearson
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 | 2023-11-01 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2023-11-01 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2023-11-01 |
Proprietary Names
Optimotion Implants Porous Metal-Backed Patella
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility