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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 K190658
Device Name MIS Bunion Plating System
Applicant
Crossroads Extremity Systems, LLC
6055 Primacy Pkwy., Suite 140
Memphis,  TN  38119
Applicant Contact Chad Hollis
Correspondent
Mrc-X, LLC
6075 Poplar Ave.
Memphis,  TN  38119
Correspondent Contact Theresa Leister
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/14/2019
Decision Date 04/12/2019
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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