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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 K210290
Device Name JACE Medical Thoracic Plating System
Applicant
Jace Medical, LLC
3516 Commerce Dr.
Warsaw,  IN  46850
Applicant Contact Scott Steffensmeier
Correspondent
MRC Global
9085 E. Mineral Circle,
Suite 110
Centennial,  CO  80112
Correspondent Contact Dawn N. Norman
Regulation Number888.3030
Classification Product Code
HRS  
Date Received02/02/2021
Decision Date 04/30/2021
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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