Name: Predicase
Price: 199 USD

K-number	K113561
Device name	TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
Applicant	Zimmer Trabecular Metal Technology
Product code	MAX
Device class	Class II
Decision date	May 29, 2012
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION

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