Clearance Summary
SILEX SACROILIAC JOINT FUSION SYSTEM received FDA 510(k) clearance under submission number K140079, sponsored by X-Spine Systems, 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 2014-03-25.
- Submission: K140079
- Applicant / Sponsor: X-Spine Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2014-03-25
Classification & Regulation
This clearance is catalogued under FDA product code OUR and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.