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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, fixation, bone
510(k) Number K190722
Device Name TriMAX Implant System
Applicant
CrossRoads Extemity Systems, LLC
6055 Primacy Pkwy Suite 140
Memphis,  TN  38119
Applicant Contact Chad Hollis
Correspondent
MRC X, LLC
6075 Poplar Avenue
Memphis,  TN  38119
Correspondent Contact Theresa Leister
Regulation Number888.3030
Classification Product Code
JDR  
Date Received03/20/2019
Decision Date 08/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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