Clearance Summary
Endoskeleton TCS Interbody Fusion Device received FDA 510(k) clearance under submission number K191565, sponsored by Titan Spine, 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 2019-08-06.
- Submission: K191565
- Applicant / Sponsor: Titan Spine, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2019-08-06
Classification & Regulation
This clearance is catalogued under FDA product code OVE and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.