Clearance Summary
UHR Bipolar Implants, Restoration GAP II Implants received FDA 510(k) clearance under submission number K222632, sponsored by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-10-21.
- Submission: K222632
- Applicant / Sponsor: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3360
- Decision date: 2022-10-21
Classification & Regulation
This clearance is catalogued under FDA product code KWL and 21 CFR 888.3360, within the Orthopedic review panel as a Class II device.