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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 K172279
Device Name PMT Posterior Fixation System
Applicant
Providence Medical Technology, Inc.
1331 N. California Blvd., Suite 320
Walnut Creek,  CA  94596
Applicant Contact Edward Liou
Correspondent
Providence Medical Technology, Inc.
1331 N. California Blvd., Suite 320
Walnut Creek,  CA  94596
Correspondent Contact Edward Liou
Regulation Number888.3075
Classification Product Code
NKG  
Date Received07/28/2017
Decision Date 09/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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