510(k) Report

Devices descending from K071668

582 later devices reach Orthobiom Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K191217Jazz PFImplanet, S.A.20190—
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+5K190751Connector SystemOrthofix, Inc.20193—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K173117NuVasive® VersaTie™ SystemNuvasive, Inc.20172—
+5K172021LigaPASSMedicrea International SA201711—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K142798PASS LP Spinal SystemMedicrea International SA201584—
+5K150049PASS LP Spinal SystemMedicrea International20150—
+5K141398Pass LP Spinal SystemMedicrea International SA2015101
+5K140738Pass LP Spinal SystemMedicrea International201447—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K132574Pass LP Spinal SystemMedicrea International20130—
+5K132575Pass LP Spinal SystemMedicrea International20130—
+5K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+6K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+6K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA20222—
+6K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+6K202771CD Horizon Spinal SystemMedtronic202021—
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated20190—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K173506LigaPASSMedicrea International SA20189—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+6K160640PASS XS Spinal SystemMedicrea International SA20160—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K161627PASS LP Spinal SystemMedicrea International SA20167—
+6K153413PASS LP Spinal SystemMedicrea International SA20160—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+6K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—