Name: Predicase
Price: 199 USD

K-number	K093943
Device name	BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM
Applicant	Smith & Nephew Inc., Endoscopy Div.
Product code	MBI
Device class	Class II
Decision date	Mar 5, 2010
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM

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