Clearance Summary
ROGOZINSKI THORACOLUMBAR SPINAL ROD received FDA 510(k) clearance under submission number K954696, sponsored by Smith & Nephew Richards, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1996-03-11.
- Submission: K954696
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 1996-03-11
Classification & Regulation
This clearance is catalogued under FDA product code KWP and 21 CFR 888.3050, within the Orthopedic review panel as a Class II device.