Clearance Summary
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) received FDA 510(k) clearance under submission number K014072, sponsored by Disc-O-Tech Medical Technologies, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2002-03-08.
- Submission: K014072
- Applicant / Sponsor: Disc-O-Tech Medical Technologies, Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3390
- Decision date: 2002-03-08
Classification & Regulation
This clearance is catalogued under FDA product code KWY and 21 CFR 888.3390, within the Orthopedic review panel as a Class II device.