K-number	K153122
Device name	Endoskeleton(r) TCS System
Applicant	Titan Spine, LLC
Product code	OVE
Device class	Class II
Decision date	Dec 14, 2015
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Endoskeleton(r) TCS System

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