Clearance Summary
APR METASUL ACETABULAR INSERT received FDA 510(k) clearance under submission number K993569, sponsored by Sulzermedica. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1999-12-01.
- Submission: K993569
- Applicant / Sponsor: Sulzermedica
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class III
- Regulation citation: 21 CFR 888.3330
- Decision date: 1999-12-01
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.