FDA Registration
Active
🇺🇸 United States
IDUO IJIG INSTRUMENTS
Reg #: 3004153240
·
FEI: 3004153240
·
Expires 2025
Products
1
Proprietary Names
20
Establishment Types
1
Classifications
1
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
- K053488
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, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2007-03-06 |
Proprietary Names
IDUO IJIG INSTRUMENTS
IDUO KNEE REPLACEMENT SYSTEM
IDUO IJIG COMPONENTS
IDUO BICOMPARTMENTAL RESURFACING
IDUO BICOMPARTMENTAL KNEE REPLACEMENT
IDUO IJIG ANCILLARY INSTRUMENTS
IDUO BICOMPARTMENTAL RESURFACING SYSTEM
IDUO PARTIAL KNEE REPLACEMENT SYSTEM
IDUO KNEE RESURFACING SYSTEM
IDUO KNEE REPLACEMENT
IDUO IJIGS
IDUO KNEE REPAIR SYSTEM
IDUO KNEE RESURFACING
IDUO KRS
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
IDUO BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
IDUO BICOMPARTMENTAL KNEE REPAIR
IDUO PARTIAL KNEE REPLACEMENT
IDUO
IDUO KNEE REPAIR
Establishment Types
Manufacture Medical Device