FDA Registration
Active
🇺🇸 United States
Cordera Trial Neck 132deg 36.5mm
Reg #: 3004153240
·
FEI: 3004153240
·
Expires 2025
Products
4
Proprietary Names
9
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
- K202484
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 |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2020-09-25 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2020-09-25 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2020-09-25 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2020-09-25 |
Proprietary Names
Cordera Trial Neck 132deg 36.5mm
Cordera Hip System
Radel Liner Impactors 32mm
Radel Liner Impactors 40mm
Cordera Trial Neck 127Degree 36.5mm
Cordera Trial Neck 132degree 29mm
Radel Liner Impactors 36mm
Radel Liner Impactors 28mm
Cordera Trial Neck 127degree 29mm
Establishment Types
Manufacture Medical Device