Clearance Summary
Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device received FDA 510(k) clearance under submission number K191581, sponsored by Titan 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 2020-01-08.
- Submission: K191581
- Applicant / Sponsor: Titan Spine, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2020-01-08
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.