Clearance Summary
ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED received FDA 510(k) clearance under submission number K901240, sponsored by Med-Tek Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1990-03-26.
- Submission: K901240
- Applicant / Sponsor: Med-Tek Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3350
- Decision date: 1990-03-26
Classification & Regulation
This clearance is catalogued under FDA product code JDI and 21 CFR 888.3350, within the Orthopedic review panel as a Class II device.