Name: Predicase
Price: 199 USD

K-number	K092914
Device name	WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES
Applicant	Medshape Solutions
Product code	MBI
Device class	Class II
Decision date	Dec 9, 2009
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES

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