Triathlon® Hinge Knee System
FDA 510(k) clearance K223528 · decided 2023-01-20
Clearance details
- K-number
- K223528
- Device name
- Triathlon® Hinge Knee System
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2022-11-23
- Decision date
- 2023-01-20
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- KRO
- Device class
- 2
- Regulation number
- 888.3510
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.