Clearance Summary
ULTIUM SPINAL PLATING SYSTEM received FDA 510(k) clearance under submission number K962784, sponsored by Smith & Nephew, Inc., Orthopaedic Div.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1996-10-02.
- Submission: K962784
- Applicant / Sponsor: Smith & Nephew, Inc., Orthopaedic Div.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 1996-10-02
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.