Clearance Summary
FIXATION PIN OR ROD received FDA 510(k) clearance under submission number K970036, sponsored by United States Surgical, A Division of Tyco Healthc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1997-03-25.
- Submission: K970036
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1997-03-25
Classification & Regulation
This clearance is catalogued under FDA product code HTY and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.