IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
FDA 510(k) clearance K132640 · decided 2013-12-05
Clearance details
- K-number
- K132640
- Device name
- IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
- Applicant
- Conformis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-23
- Decision date
- 2013-12-05
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- HSX
- Device class
- 2
- Regulation number
- 888.3520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: recall (Z-0138-2016) | ConforMIS, Inc. | 2015-10-21 |
| ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M572206 recall (Z-0139-2016) | ConforMIS, Inc. | 2015-10-21 |
| ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: recall (Z-0140-2016) | ConforMIS, Inc. | 2015-10-21 |