K-number	K112444
Device name	ANATOMIC PEEK CERVICAL FUSION SYSTEM
Applicant	Medtronic Sofamor Danck USA, Inc.
Product code	ODP
Device class	Class II
Decision date	Nov 15, 2011
Decision	Substantially Equivalent
Regulation	888.3080

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View the full FDA submission: accessdata.fda.gov

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ANATOMIC PEEK CERVICAL FUSION SYSTEM

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