K-number	K013553
Device name	PRE-LOADED ULTRAFIX RC
Applicant	Linvatec Corp.
Product code	MBI
Device class	Class II
Decision date	Dec 19, 2001
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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PRE-LOADED ULTRAFIX RC

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