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510(k) Premarket Notification Database

Device Classification Name appliance, fixation, spinal interlaminal
510(k) NumberK070638
Device NameTHEKEN ATOLL CERVICO-THORACIC SYSTEM
Applicant
THEKEN SPINE LLC
283 e waterloo rd.
akron,  OH  44319
Contactdale davison
Regulation Number888.3050
Classification Product Code
KWP
Subsequent Product Code
MNI
Date Received03/07/2007
Decision Date 05/30/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Statement/Summary/Purged Status Summary only
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No

Database Updated 03/06/2009

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