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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K180025
Device Name Centurion POCT System
Applicant
Orthofix, Inc.
3451 Plano Pkwy.
Lweisville,  TX  75056
Applicant Contact Jacki Koch
Correspondent
Orthofix, Inc.
3451 Plano Pkwy.
Lweisville,  TX  75056
Correspondent Contact Jacki Koch
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received01/03/2018
Decision Date 01/22/2018
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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