FDA Registration
Active
🇺🇸 United States
Identity Imprint CR insert trial 18mm
Reg #: 3004153240
·
FEI: 3004153240
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
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
- K230844
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 | 2023-05-01 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2023-05-01 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2023-05-01 |
Proprietary Names
Identity Imprint CR insert trial 18mm
Identity Imprint CS Insert
Identity Imprint CS Insert trial
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device