510(k) Report

Devices descending from K963741

188 later devices reach Leibinger Luhr Small Craniomaxillofacial Bone Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K051165KLS Martin Sternal TalonKLS-Martin L.P.200662—
+6K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG20060—
+7K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+7K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+7K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+7K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+7K183172Stryker SternalPlate SystemStryker20191—
+7K181539OSSDSIGN CranioplugOssdsign AB20181—
+7K181607Thorecon Rigid Fixation SystemA & E Medical Corporation201805
+7K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201643—
+7K161896Biomet Microfixation Sternal Closure SystemBiomet Microfixation20164—
+7K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation201543—
+7K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation201523—
+7K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+7K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+8K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+8K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+8K243491SternalPlate ExpansionStryker Leibinger GmbH & Co KG20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda.20240—
+8K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH20240—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K212782SternaLock Sternal Closure SystemBiomet Microfixation20220—
+8K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)202040—
+8K182179AdvantageRib Anterior SystemSig Medical Corp.20180—
+8K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation201640—
+8K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+8K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+8K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201611—
+8K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201513—
+8K101484Compressyn BandDallen Medical20115—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+9K221412ARIX Rib SystemJeil Medical Corporation20221—
+9K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation20168—
+9K130431Compressyn BandDallen Medical, Inc.20134—
+10K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+10K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K212608RibFix Blu Thoracic Fixation SystemBiomet Microfixation20224—
+10K190409MatrixRIB Fixation SystemDePuy Synthes20193—
+10K133858Tensyn BandDallen Medical, Inc.20143—
+11K261054RibPlate SystemStryker Leibinger GmbH & Co KG20260—
+11K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+11K252166RIB LINK™ Fixation SystemGlobus Medical, Inc.20260—
+11K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+11K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+11K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+11K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—
+11K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC20190—
+11K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+12K143092Tensyn PlugDallen Medical, Inc.20151—
+13K150359Tensyn PlugDallen Medical, Inc.20150—