510(k) Report

Devices descending from K914966

580 later devices reach TSRH Central Post Hooks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+8K230026SqualeImplanet, S.A.20230—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+8K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+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—
+8K190376PASS LP Spinal SystemMedicrea International SA201915
+8K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+8K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+8K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+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
+8K161842Overwatch Spine SystemAmendia, Inc.201661
+8K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+8K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+8K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+8K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+8K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+9K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+9K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+9K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+9K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+9K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+9K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+9K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+9K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+9K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+9K182721Choice Spine Navigation SystemChoicespine, LP20192—
+9K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+9K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+9K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+9K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+9K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+9K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+10K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+10K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+10K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+10K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+10K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+10K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+10K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+10K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+10K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+10K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+10K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+10K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+10K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+10K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+10K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+10K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+11K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+11K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+11K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+11K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+11K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+12K253943Tiger 2 SystemZavation Medical Products, LLC20260—