510(k) Report

Devices descending from K022949

867 later devices reach Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+5K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+5K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+5K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+5K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+5K172194Connector SystemOrthofix, Inc.2017162
+5K171881JAZZ Passer BandImplanet, S.A.20170—
+5K171838TiLock2 Spinal SystemGenesys Spine20174—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+5K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K161016Z-Clamp ISP SystemZavation, LLC20160—
+5K162143FixxSure® X-LinkInnovasis, Inc.20160—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K160698LigaPASSMedicrea International SA201612—
+5K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+5K161265NuVasive® VersaTie SystemNu Vasive, Incorporated20163—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+5K151740JAZZ SystemImplanet, S.A.201512—
+5K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K143759JAZZ SystemImplanet, S.A.201513—
+5K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+5K150449LITe Plate SystemStryker Corp.201524—
+5K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K133617Jazz SystemImplanet, S.A.201414—
+5K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+5K131533Cayman MI Plate SystemK2m, Inc.201372—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K123138Pass LP Spinal SystemMedicrea International2013132—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K110906Apex Spine SystemSpinecraft, LLC2011103—
+5K090320Conquest Spinal SystemLife Spine20092—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—