Clearance Summary
ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM received FDA 510(k) clearance under submission number K912420, sponsored by Scientific Research. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1991-09-23.
- Submission: K912420
- Applicant / Sponsor: Scientific Research
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 1991-09-23
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.