Name: Predicase
Price: 199 USD

K-number	K080979
Device name	STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
Applicant	Biomet Manufacturing Corp
Product code	KWY
Device class	Class II
Decision date	Oct 31, 2008
Decision	Substantially Equivalent
Regulation	888.3390

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Source

View the full FDA submission: accessdata.fda.gov

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STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT

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