Clearance Summary
PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT received FDA 510(k) clearance under submission number K964395, sponsored by Hayes Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1997-01-27.
- Submission: K964395
- Applicant / Sponsor: Hayes Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 1997-01-27
Classification & Regulation
This clearance is catalogued under FDA product code LZO and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.