Clearance Summary
Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device received FDA 510(k) clearance under submission number K192018, 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 2019-08-16.
- Submission: K192018
- Applicant / Sponsor: Titan Spine, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2019-08-16
Classification & Regulation
This clearance is catalogued under FDA product code ODP and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.