Name: Predicase
Price: 199 USD

K-number	K071927
Device name	MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
Applicant	Depuy Spine, A Johnson & Johnson Company
Product code	NDN
Device class	Class II
Decision date	Nov 21, 2007
Decision	Substantially Equivalent
Regulation	888.3027

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT

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