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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 K261345
Device Name Pediatric Nailing Platform Femur
Applicant
OrthoPediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46582
Applicant Contact Jessica Powers
Correspondent
OrthoPediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact Jessica Powers
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/23/2026
Decision Date 09/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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