Clearance Summary
ANTERIOR CERVICAL PLATING SYSTEM received FDA 510(k) clearance under submission number K984342, sponsored by United States Surgical, A Division of Tyco Healthc. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1998-12-30.
- Submission: K984342
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 1998-12-30
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.