Clearance Summary
ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED received FDA 510(k) clearance under submission number K033943, sponsored by Centerpulse Orthopedics, 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 2004-10-18.
- Submission: K033943
- Applicant / Sponsor: Centerpulse Orthopedics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class III
- Regulation citation: 21 CFR 888.3330
- Decision date: 2004-10-18
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.