K-number	K103287
Device name	SYNTHES 6.0 COCR AND CPT TI-3 RODS
Applicant	Synthes Spine
Product code	NKB
Device class	Class II
Decision date	Jan 5, 2011
Decision	Substantially Equivalent
Regulation	888.3070

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View the full FDA submission: accessdata.fda.gov

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SYNTHES 6.0 COCR AND CPT TI-3 RODS

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