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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 K190430
Device Name OsteoCentric Bone Plate and Screw System
Applicant
Osteocentric Trauma
5113 Southwest Pkwy., Suite 150
Austin,  TX  79735
Applicant Contact Todd Evans
Correspondent
Empirical Consulting, LLC
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith Lee May
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received02/22/2019
Decision Date 03/22/2019
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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