Identity Imprint Knee Replacement System
FDA 510(k) clearance K210191 · decided 2021-05-06
Clearance details
- K-number
- K210191
- Device name
- Identity Imprint Knee Replacement System
- Applicant
- Conformis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-01-25
- Decision date
- 2021-05-06
- Days to decision
- 101 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
| Record | Firm | Date |
|---|---|---|
| Identity Imprint PS Tibial Tray Size 4: Lot 540287 recall (Z-1591-2024) | Conformis, Inc. | 2024-04-17 |