Clearance Summary
H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED received FDA 510(k) clearance under submission number K901626, 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 1990-08-14.
- Submission: K901626
- Applicant / Sponsor: Med-Tek Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class III
- Regulation citation: 21 CFR 888.3330
- Decision date: 1990-08-14
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.