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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(k) Number K181630
Device Name Revolution External Plating System
Applicant
New Standard Device DBA Metalogix
4766 Research Drive
San Antonio,  TX  78240
Applicant Contact Bryant Phamvu
Correspondent
Empirical Consulting LLC
4628 Northpark Dr
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3030
Classification Product Code
KTT  
Date Received06/20/2018
Decision Date 05/29/2019
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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