K-number	K062273
Device name	SPACER-G TEMPORARY HIP PROSTHESIS
Applicant	Tecres S.P.A.
Product code	KWL
Device class	Class II
Decision date	May 22, 2008
Decision	Substantially Equivalent
Regulation	888.3360

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Source

View the full FDA submission: accessdata.fda.gov

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SPACER-G TEMPORARY HIP PROSTHESIS

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