510(k) Report

Devices descending from K082375

10 later devices reach Orthopediatrics Pediflex Flexible Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201838PediFlex Flexible Nail SystemOrthoPediatrics Corp.20211—
+1K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAILOrthofix Srl20170—
+1K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.201561
+2K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.20250—
+2K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc.20205—
+3K250197Estremo Fibular NailCitieffe S.R.L.20250—
+3K241983Fassier-Duval Telescoping IM SystemOrthopediatrics Canada Ulc Dba Pega Medical20250—
+3K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+4K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+5K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—