Clearance Summary
RESURFACE PROSTHESES FOR HIP JOINT received FDA 510(k) clearance under submission number K761324, sponsored by Holco Instrument 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 1977-01-05.
- Submission: K761324
- Applicant / Sponsor: Holco Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3400
- Decision date: 1977-01-05
Classification & Regulation
This clearance is catalogued under FDA product code KXA and 21 CFR 888.3400, within the Orthopedic review panel as a Class II device.