FDA Registration
Active
🇺🇸 United States
Identity Imprint Porous CR KRS
Reg #: 3004153240
·
FEI: 3004153240
·
Expires 2025
Products
4
Proprietary Names
7
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ConforMIS, Inc.
- Registration Number
- 3004153240
- FEI Number
- 3004153240
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 600 Research Dr
- City
- Wilmington
- State
- MA
- ZIP
- 01887
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223316
Owner / Operator
- Firm Name
- restor3d, Inc.
- Operator Number
- 9058483
- Address
- 4001 NC-54, Suite 3160
- City
- Durham
- State
- NC
- Postal Code
- 27709
- Country
- US
- Correspondent
- Brianna Prindle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2023-08-01 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2023-08-01 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2023-08-01 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2023-08-01 |
Proprietary Names
Identity Imprint Porous CR KRS
Identity Imprint Porous CR Tibial Implants
Identity Imprint Porous CR Femoral implants
Identity Imprint Porous CR Oval Patella Implants
Identity Imprint Porous CR iJigs
Identity Imprint Porous CR Round Patella Implants
Identity Imprint Porous CR Ancillary Reusable instrument tray with lid
Establishment Types
Manufacture Medical Device