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510(k) Premarket Notification Database

Device Classification Name:	ORTHOSIS, FIXATION, PEDICLE, SPINAL
Regulation Number:	888.3070 [See Other Products with this regulation number]
510(k) Number:	K032037
Device Name:	CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
Applicant:	MEDTRONIC SOFAMOR DANEK PYRAMID PLACE MEMPHIS, TN 38132
Contact:	RICHARD TREHARNE
Product Code:	MNI [See Other Manufacturers that make this Product]
Date Received:	07-01-2003
Decision Date:	09-04-2003
Decision:	SE
Advisory Committee:	OR
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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