Clearance Summary
CENTRE-DRIVE DRILL-FREE SCREW received FDA 510(k) clearance under submission number K971297, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1997-05-08.
- Submission: K971297
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1997-05-08
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.