Clearance Summary
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) received FDA 510(k) clearance under submission number K030972, sponsored by Disc-O-Tech Medical Technologies, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2003-05-30.
- Submission: K030972
- Applicant / Sponsor: Disc-O-Tech Medical Technologies, Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3360
- Decision date: 2003-05-30
Classification & Regulation
This clearance is catalogued under FDA product code KWL and 21 CFR 888.3360, within the Orthopedic review panel as a Class II device.