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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K162153
Device Name Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
Applicant
Ascension Orthopedics
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Applicant Contact GABRIELLA BECKER
Correspondent
Ascension Orthopedics
8700 Cameron Rd.
Austin,  TX  78701
Correspondent Contact Blesson Abraham
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/02/2016
Decision Date 07/14/2017
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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