Clearance Summary
Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti received FDA 510(k) clearance under submission number K150643, sponsored by Centinel Spine, 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 2015-06-08.
- Submission: K150643
- Applicant / Sponsor: Centinel Spine, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2015-06-08
Classification & Regulation
This clearance is catalogued under FDA product code OVD and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.