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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

Titan Spine, Inc. · Class II · Cleared Aug 16, 2019

K-numberK192018
Device nameEndoskeleton 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
ApplicantTitan Spine, Inc.
Product codeODP
Device classClass II
Decision dateAug 16, 2019
DecisionSubstantially Equivalent
Regulation888.3080
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View the full FDA submission: accessdata.fda.gov

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