K-number	K161597
Device name	Tyber Medical BioTy® Nanotopography Trauma Screw
Applicant	Tyber Medical, LLC
Product code	HWC
Device class	Class II
Decision date	Nov 16, 2016
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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Tyber Medical BioTy® Nanotopography Trauma Screw

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