Clearance Summary
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) received FDA 510(k) clearance under submission number K003215, sponsored by Disco-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 2000-12-27.
- Submission: K003215
- Applicant / Sponsor: Disco-O-Tech Medical Technologies, Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2000-12-27
Classification & Regulation
This clearance is catalogued under FDA product code JDS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.