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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K111183
Device Name ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
Applicant
Orthofix, Inc.
3451 Plano Pkwy.
Lewisville,  TX  75056
Applicant Contact DARLA CHEW
Correspondent
Orthofix, Inc.
3451 Plano Pkwy.
Lewisville,  TX  75056
Correspondent Contact DARLA CHEW
Regulation Number888.3050
Classification Product Code
KWP  
Date Received04/27/2011
Decision Date 05/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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