510(k) Report

Devices descending from K973836

529 later devices reach Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K213417Ghost Spacer SystemLife Spine, Inc.20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+7K150417Astra Spine SystemSpinecraft, LLC201521—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+7K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+7K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+7K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+8K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+8K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+8K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+8K230026SqualeImplanet, S.A.20230—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+8K211323ASTRA Spine SystemSpinecraft, LLC202112—
+8K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K182721Choice Spine Navigation SystemChoicespine, LP20192—
+8K172115Navigated Instrument SystemOrthofix, Inc.20184—
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+8K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+8K162786PASS LP Spinal SystemMedicrea International SA20176—
+8K161842Overwatch Spine SystemAmendia, Inc.201661
+8K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+8K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+8K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+9K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+9K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+9K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+9K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+9K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+9K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+9K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+9K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—