510(k) Report

Devices descending from K972332

81 later devices reach Aesculap Craniofix Titanium Clamp System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L20104—
+1K062857KLS Martin Quick DiscKLS Martin L.P.200662—
+1K040864Craniofix and CRANIOFIX2 Titanium Clamp SystemAesculap200467—
+1K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp.200363—
+1K030378Stryker Leibinger Cranial Fixation SystemStryker Instruments20030—
+1K020088Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc.20022—
+1K013050The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc.20014—
+1K993990Leibinger Quik Disk Titanium Clamp SystemStryker Instruments20006—
+2K130447Speedy Flap SystemJeil Medical Corporation20140—
+2K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemNeos Surgery S.L20133—
+2K122353Crainfix 2 Titanium Clamp SystemAesculap, Inc.20121—
+2K082175Mofication to: Modified Plate Design for Bioplate Zip Craniotomy FixationBioplate, Inc.20080—
+2K070901Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc.20071—
+2K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+2K063017Aesculap Sternumfix Sternal Closure SystemAesculap, Inc.20061—
+2K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc.20050—
+3K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+3K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L20240—
+3K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.20200—
+3K160739Cranial COVERNeos Surgery S.L20161—
+3K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+3K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+3K142484Sternal Closure SystemJace Medical, LLC20141—
+3K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+3K101484Compressyn BandDallen Medical20115—
+3K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L.20090—
+4K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+4K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+4K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+4K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+4K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+4K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+4K130431Compressyn BandDallen Medical, Inc.20134—
+5K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+5K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+5K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+5K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+5K133858Tensyn BandDallen Medical, Inc.20143—
+6K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+6K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K143092Tensyn PlugDallen Medical, Inc.20151—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K150359Tensyn PlugDallen Medical, Inc.20150—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—