Clearance Summary
AXLE INTERSPINOUS FUSION SYSTEM received FDA 510(k) clearance under submission number K130438, 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 2013-06-27.
- Submission: K130438
- Applicant / Sponsor: X-Spine Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 2013-06-27
Classification & Regulation
This clearance is catalogued under FDA product code PEK and 21 CFR 888.3050, within the Orthopedic review panel as a Class II device.