Name: Predicase
Price: 199 USD

K-number	K081598
Device name	SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE
Applicant	Kfx Medical
Product code	MBI
Device class	Class II
Decision date	Jul 3, 2008
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE

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