510(k) Report

Devices descending from K841189

2,425 later devices reach Oec/Rezaian Spinal Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+6K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+6K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+6K153404Zavation Spinal SystemZavation, LLC20161—
+6K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+6K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K151939COALITION SpacersGlobus Medical, Inc.2016152—
+6K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+6K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+6K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+6K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+6K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+6K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+6K152304Tritanium PL CageStryker20154481
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K143479Bluefin Interbody SystemTides Medical20152—
+6K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+6K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+6K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+6K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+6K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+6K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+6K142392Zavation Posterior LEIFZavation, LLC20150—
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+6K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+6K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+6K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+6K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+6K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+6K143616AccuLIF TL and PL CageStryker Corporation20154694
+6K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+6K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+6K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+6K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K142271Zavation Z-Link LumbarZavation, LLC20149—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+6K141135Juliet LLSpineart2014146—
+6K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+6K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+6K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+6K141896Coroent SystemNu Vasive, Incorporated2014480—
+6K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+6K141850Flospine Pedicle Screw SystemFlospine20140—
+6K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+6K142381Xia 3 Spinal SystemStryker Corp.201483—
+6K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+6K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+6K1421124WEB Spinal Implant Products4Web, Inc.201433—
+6K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K140280ForticoreNanovis, LLC20149—
+6K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+6K141044M.U.S.T. ExtensionMedacta International201416—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K140411Altera SpacerGlobus Medical, Inc.201419122
+6K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+6K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+6K133200Stalif C (R)Centinel Spine, Inc.201410—
+6K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+6K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K140303Alamo TAlliance Partners, LLC20140—
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+6K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—