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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 K172194
Device Name Connector System
Applicant
Orthofix Inc.
3451 Plano Parkway
Lewisville,  TX  75056
Applicant Contact Jacki Koch
Correspondent
Orthofix Inc.
3451 Plano Parkway
Lewisville,  TX  75056
Correspondent Contact Jacki Koch
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Codes
KWP   KWQ   NKB  
Date Received07/21/2017
Decision Date 08/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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