K-number	K082463
Device name	PROGENIX
Applicant	Medtronic Sofamor Danek
Product code	NUN
Device class	Class II
Decision date	Nov 10, 2008
Decision	Substantially Equivalent
Regulation	872.3930

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Source

View the full FDA submission: accessdata.fda.gov

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PROGENIX

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