510(k) K142589

Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL by Titan Spine, LLC — Product Code MAX

K142589 is an FDA 510(k) premarket notification submitted by Titan Spine, LLC for the device "Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL". The FDA issued a decision of Substantially Equivalent on October 17, 2014. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Titan Spine, LLC has at least 10 other 510(k) clearances on record.