Clearance Summary
RING UPM TOTAL HIP REPLACEMENT received FDA 510(k) clearance under submission number K864515, sponsored by Downs Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1987-03-13.
- Submission: K864515
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class III
- Regulation citation: 21 CFR 888.3330
- Decision date: 1987-03-13
Classification & Regulation
This clearance is catalogued under FDA product code KWA and 21 CFR 888.3330, within the Orthopedic review panel as a Class III device.