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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K183317
Device Name AdvantageRib System
Applicant
SIG Medical Corporation
238 East Chocolate Avenue, Suite 2
Hershey,  PA  17033
Applicant Contact Andrew Davison
Correspondent
JALEX Medical, LLC.
30311 Clemens Road, Suite #5D
Westlake,  OH  44145
Correspondent Contact Lauren Smith
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/30/2018
Decision Date 02/14/2019
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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