510(k) Report

Devices descending from K011076

110 later devices reach Lorenz Sternal Closure System with Modular Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC20190—
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K143092Tensyn PlugDallen Medical, Inc.20151—
+8K150359Tensyn PlugDallen Medical, Inc.20150—