510(k) K173535

Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device by Titan Spine, LLC — Product Code ODP

K173535 is an FDA 510(k) premarket notification submitted by Titan Spine, LLC for the device "Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device". The FDA issued a decision of Substantially Equivalent on February 13, 2018. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Titan Spine, LLC has at least 10 other 510(k) clearances on record.