Clearance Summary
R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM received FDA 510(k) clearance under submission number K032752, sponsored by R&B Surgical Solutions, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2003-12-03.
- Submission: K032752
- Applicant / Sponsor: R&B Surgical Solutions, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2003-12-03
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.