510(k) Report

Devices descending from K071668

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121630Range Spinal SystemK2m, Inc.2012127—
+1K113666Xia 3 Spinal SystemStryker Spine2012251—
+1K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010581—
+2K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+2K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+2K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K142381Xia 3 Spinal SystemStryker Corp.201483—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K132303Implanet Spine SystemImplanet, S.A.201315—
+2K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+2K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011261—
+2K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+2K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011269—
+2K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.2010261
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+3K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K172206NAJA™ Ligament Correction SystemCousin Biotech Sas20182—