Clearance Summary
DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS received FDA 510(k) clearance under submission number K053536, sponsored by Zimmer GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-03-16.
- Submission: K053536
- Applicant / Sponsor: Zimmer GmbH
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class III
- Regulation citation: 21 CFR 888.3330
- Decision date: 2006-03-16
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.