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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
Virak Orthopedics, LLC
620 Essex St
harrison,  NJ  07029
Applicant Contact virak tan
6075 Poplar Ave Suite 500
memphis,  TN  38119
Correspondent Contact christine scifert
Regulation Number888.3040
Classification Product Code
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