iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System
FDA 510(k) clearance K193105 · decided 2020-03-13
Clearance details
- K-number
- K193105
- Device name
- iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System
- Applicant
- Conformis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-11-08
- Decision date
- 2020-03-13
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Billerica, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.