Clearance Summary
TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance under submission number K022344, sponsored by Centerpulse Spine-Tech, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2002-09-24.
- Submission: K022344
- Applicant / Sponsor: Centerpulse Spine-Tech, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2002-09-24
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.