Clearance Summary
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION received FDA 510(k) clearance under submission number K001535, sponsored by Ortho Tec, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2001-03-20.
- Submission: K001535
- Applicant / Sponsor: Ortho Tec, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 2001-03-20
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.