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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K190321
Device Name Pediatric Nailing PlatformFemur
Applicant
OrthoPediatrics, Corp.
2850 Frontier Drive
warsaw,  IN  46582
Applicant Contact jen gregory
Correspondent
OrthoPediatrics, Corp.
2850 Frontier Drive
warsaw,  IN  46582
Correspondent Contact jen gregory
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/13/2019
Decision Date 10/09/2019
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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