510(k) Report

Devices descending from K072253

1,250 later devices reach Synfix-LR Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+3K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+3K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+3K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+3K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+3K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+3K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+3K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+3K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+3K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+3K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+3K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+3K141187Impix Alif S/aMedicrea International SA201501
+3K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+3K141942Midline II TICentinel Spine, Inc.2014459—
+3K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+3K141791Biomet Fusion SystemBiomet Spine2014128—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K140280ForticoreNanovis, LLC20149—
+3K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+3K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+3K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+3K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+3K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+3K123758Tasmin RSignus Medizintechnik GmbH20141—
+3K133286Midline (TM)Centinel Spine, Inc.2014460—
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+3K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+3K130461Stalif XCentinel Spine, Inc.201313—
+3K131449Coalition SpacerGlobus Medical, Inc.2013235—
+3K131077Life Spine Plateau Spacer SystemLife Spine201310—
+3K131547Lanx Fusion SystemLanx, Inc.20131631
+3K131671MectalifMedacta International201322—
+3K131372Mobis IISignus Medizintechnik GmbH2013462—
+3K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+3K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K122444Cervical CageEisertech, LLC201222—
+3K122317Tetris IISignus Medizintechnik GmbH20122—
+3K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+3K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+3K121116Plateau Spacer SystemLife Spine201213—
+3K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+3K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+3K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+3K111272Rhausler Plage Anterior Cervical Fusion SystemRhausler, Inc.20117—
+3K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+3K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+3K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+3K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+3K103369Vault Alif SystemSpinal USA201110—
+3K110045Interfuse DA Invertebral Body Fusion DeviceVertebral Technologies, Inc.20110—
+3K102277Interfuse T Invertebral Body Fusion DeviceVertebral Technologies, Inc.201098—
+3K101301Stalif MidlineCentinel Spine2010474—
+3K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+3K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+3K093864Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp.2010637—
+3K092574Esl Spinal SystemEbi, L.P.2010181—
+3K092017Pivotec Lumbar Interbody Fusion Device (Lifd)Captiva Spine, Inc.200924—
+3K092336C-Thru Spinal SystemEbi, L.P.2009492—
+3K091381Ibex Spinal SystemEbi, L.P.2009181—
+3K081711Lucent Magnum+Spinal Elements, Inc.20080—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—