Clearance Summary
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM received FDA 510(k) clearance under submission number K992276, sponsored by Sulzer Spine-Tech. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1999-10-01.
- Submission: K992276
- Applicant / Sponsor: Sulzer Spine-Tech
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 1999-10-01
Classification & Regulation
This clearance is catalogued under FDA product code MNI and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.