Clearance Summary
S.A.F. ACETABULAR CUP WITH POROUS COATING received FDA 510(k) clearance under submission number K896614, sponsored by Synergy Orthopaedics Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1990-01-09.
- Submission: K896614
- Applicant / Sponsor: Synergy Orthopaedics Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class III
- Regulation citation: 21 CFR 888.3320
- Decision date: 1990-01-09
Classification & Regulation
This clearance is catalogued under FDA product code JDL and 21 CFR 888.3320, within the Orthopedic review panel as a Class III device.