Name: Predicase
Price: 199 USD

K-number	K111399
Device name	SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75
Applicant	Arthrocare Corp.
Product code	MBI
Device class	Class II
Decision date	Jul 20, 2011
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75

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