Clearance Summary
FORTEX PEDICLE SCREW SYSTEM received FDA 510(k) clearance under submission number K120832, sponsored by X-Spine Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2012-10-23.
- Submission: K120832
- Applicant / Sponsor: X-Spine Systems, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2012-10-23
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.