510(k) Report

Devices descending from K013954

117 later devices reach Lorenz Self Drilling Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K212608RibFix Blu Thoracic Fixation SystemBiomet Microfixation20224—
+7K190409MatrixRIB Fixation SystemDePuy Synthes20193—
+7K133858Tensyn BandDallen Medical, Inc.20143—
+8K261054RibPlate SystemStryker Leibinger GmbH & Co KG20260—
+8K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+8K252166RIB LINK™ Fixation SystemGlobus Medical, Inc.20260—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—
+8K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC20190—
+8K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+9K143092Tensyn PlugDallen Medical, Inc.20151—
+10K150359Tensyn PlugDallen Medical, Inc.20150—