UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
FDA 510(k) clearance K043570 · decided 2005-03-14
Clearance details
- K-number
- K043570
- Device name
- UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
- Applicant
- Conformis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-27
- Decision date
- 2005-03-14
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- HSX
- Device class
- 2
- Regulation number
- 888.3520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Foster City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600 recall (Z-1622-2009) | Conformis Inc | 2009-07-15 |
| ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M5 recall (Z-1623-2009) | Conformis Inc | 2009-07-15 |
| ConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M572 recall (Z-1624-2009) | Conformis Inc | 2009-07-15 |