K-number	K170650
Device name	Orthofix TrueLok Hexapod System (TL-HEX) V2.0
Applicant	Orthofix Srl
Product code	KTT
Device class	Class II
Decision date	May 10, 2017
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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Orthofix TrueLok Hexapod System (TL-HEX) V2.0

Everything you need for a 510(k) submission. Nothing you don't.