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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name component, traction, invasive
510(k) Number K192465
Device Name DigiFix Sterile Kit
Applicant
Virak Orthopedics, LLC
620 Essex St
harrison,  NJ  07029
Applicant Contact virak tan
Correspondent
MRC-X, LLC
6075 Poplar Ave Suite 500
memphis,  TN  38119
Correspondent Contact christine scifert
Regulation Number888.3040
Classification Product Code
JEC  
Date Received09/09/2019
Decision Date 10/10/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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