Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS
FDA 510(k) clearance K231233 · decided 2023-05-26
Clearance details
- K-number
- K231233
- Device name
- Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS
- Applicant
- Conformis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-28
- Decision date
- 2023-05-26
- Days to decision
- 28 days
- Clearance type
- Special
- 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 |