Clearance Summary
SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM received FDA 510(k) clearance under submission number K980288, sponsored by Spine-Tech, 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 1998-07-29.
- Submission: K980288
- Applicant / Sponsor: Spine-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 1998-07-29
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.