ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert
FDA 510(k) clearance K211609 · decided 2021-08-25
Clearance details
- K-number
- K211609
- Device name
- ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert
- Applicant
- Depuy Ireland UC
- Decision
- Substantially Equivalent
- Date received
- 2021-05-25
- Decision date
- 2021-08-25
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ringaskiddy, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.