Clearance Summary
PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems received FDA 510(k) clearance under submission number K182473, sponsored by K2m, 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 2018-12-12.
- Submission: K182473
- Applicant / Sponsor: K2m, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2018-12-12
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.