Clearance Summary
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System received FDA 510(k) clearance under submission number K143626, sponsored by Zimmer Spine, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-03-20.
- Submission: K143626
- Applicant / Sponsor: Zimmer Spine, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2015-03-20
Classification & Regulation
This clearance is catalogued under FDA product code KWQ and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.