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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 K152211
Device Name PCT System
Applicant
Centinel Spine, Inc.
900 Airport Rd., Suite 3b
West Chester,  PA  19380
Applicant Contact JESSICA STAUB
Correspondent
Centinel Spine, Inc.
900 Airport Rd., Suite 3b
West Chester,  PA  19380
Correspondent Contact Jessica Staub
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received08/07/2015
Decision Date 12/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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