510(k) Report

Devices descending from K953806

240 later devices reach Synthes (Usa) Midfacial System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K221412ARIX Rib SystemJeil Medical Corporation20221—
+8K192592Axis Plating SystemExtremity Medical, LLC20190—
+8K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation20168—
+8K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K212608RibFix Blu Thoracic Fixation SystemBiomet Microfixation20224—
+9K190409MatrixRIB Fixation SystemDePuy Synthes20193—
+9K143092Tensyn PlugDallen Medical, Inc.20151—
+10K261054RibPlate SystemStryker Leibinger GmbH & Co KG20260—
+10K252166RIB LINK™ Fixation SystemGlobus Medical, Inc.20260—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—
+10K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC20190—
+10K150359Tensyn PlugDallen Medical, Inc.20150—