Clearance Summary
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance under submission number K012305, sponsored by Sulzer Spine-Tech. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2001-08-22.
- Submission: K012305
- Applicant / Sponsor: Sulzer Spine-Tech
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2001-08-22
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.