Clearance Summary
BIOMETRIC TOTAL HIP SYSTEM received FDA 510(k) clearance under submission number K935012, sponsored by Osteo-Technology Intl., 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 1994-03-07.
- Submission: K935012
- Applicant / Sponsor: Osteo-Technology Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3350
- Decision date: 1994-03-07
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.