510(k) Report

Devices descending from K061808

410 later devices reach Darco Locking Bone Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+6K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+7K143092Tensyn PlugDallen Medical, Inc.20151—
+8K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+8K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+8K150359Tensyn PlugDallen Medical, Inc.20150—