510(k) Report

Devices descending from K083726

6 later devices reach Pedinail Intramedullary Nailing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.201843
+1K172699Agile NailOrthofix Srl20180—
+2K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+2K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+2K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp.20222—
+2K190321Pediatric Nailing PlatformFemurOrthoPediatrics Corp.20190—