Name: Predicase
Price: 199 USD

K-number	K123425
Device name	TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
Applicant	Smith & Nephew, Inc.
Product code	MBI
Device class	Class II
Decision date	Feb 20, 2013
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL

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