Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
FDA 510(k) clearance K221059 · decided 2022-05-10
Clearance details
- K-number
- K221059
- Device name
- Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
- Applicant
- Conformis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-11
- Decision date
- 2022-05-10
- Days to decision
- 29 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
No recalls on record reference this clearance.