Clearance Summary
Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL received FDA 510(k) clearance under submission number K142589, sponsored by Titan Spine, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2014-10-17.
- Submission: K142589
- Applicant / Sponsor: Titan Spine, LLC
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2014-10-17
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.