Clearance Summary
EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO received FDA 510(k) clearance under submission number K914269, sponsored by Scientific Spinal , 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 1991-12-18.
- Submission: K914269
- Applicant / Sponsor: Scientific Spinal , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 1991-12-18
Classification & Regulation
This clearance is catalogued under FDA product code KWP and 21 CFR 888.3050, within the Orthopedic review panel as a Class II device.