K-number	K032037
Device name	CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
Applicant	Medtronic Sofamor Danek
Product code	MNI
Device class	Class II
Decision date	Sep 4, 2003
Decision	Substantially Equivalent
Regulation	888.3070

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View the full FDA submission: accessdata.fda.gov

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CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)

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