Clearance Summary
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B received FDA 510(k) clearance under submission number K010901, 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 2001-06-19.
- Submission: K010901
- Applicant / Sponsor: Disc-O-Tech Medical Technologies, Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2001-06-19
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.