Clearance Summary
DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM received FDA 510(k) clearance under submission number K012173, 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 2001-09-28.
- Submission: K012173
- Applicant / Sponsor: Sulzer Spine-Tech
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 2001-09-28
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.