Clearance Summary
H.N. TOTAL HIP PROSTHESIS received FDA 510(k) clearance under submission number K901594, 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 1990-08-03.
- Submission: K901594
- Applicant / Sponsor: Med-Tek Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3360
- Decision date: 1990-08-03
Classification & Regulation
This clearance is catalogued under FDA product code LWJ and 21 CFR 888.3360, within the Orthopedic review panel as a Class II device.