510(k) Report

Devices descending from P950002

1,681 later devices reach Bak Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+2K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+2K153436LATERAL Spine Truss System4Web, Inc.20165—
+2K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+2K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+2K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+2K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+2K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+2K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+2K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+2K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+2K140348Interbody CageEisertech, LLC2015235—
+2K141187Impix Alif S/aMedicrea International SA201501
+2K142271Zavation Z-Link LumbarZavation, LLC20149—
+2K141135Juliet LLSpineart2014146—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+2K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+2K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+2K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+2K141337Arena-CSpinefrontier, Inc.20141—
+2K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+2K132907Plif Lite and Tlif LiteSintea Plustek20140—
+2K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+2K140055Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC2014267—
+2K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+2K140066Infill CervicalPinnacle Spine Group, LLC20140—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+2K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+2K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K133184Ardis Interbody SystemZimmer Spine, Inc.201420—
+2K133321Alamo CAlliance Partners, LLC20143—
+2K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+2K132790Infix Anterior Lumbar SystemZimmer Spine, Inc.201328—
+2K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+2K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+2K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K132718Integrity Spine Core SystemIntegrity Spine20131—
+2K130853Idys (TM) CClariance20132—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+2K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+2K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+2K131242Ardis Interbody SystemZimmer Spine, Inc.20130—
+2K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+2K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+2K131671MectalifMedacta International201322—
+2K121178Transcorp Acif SystemTranscorp, Inc.20130—
+2K131372Mobis IISignus Medizintechnik GmbH2013462—
+2K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+2K124034Mectalif AnteriorMedacta International201311—
+2K130548Epicage Interbody Fusion DeviceAlphatec Spine, Inc.2013602—
+2K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K123969XiphosDifusion Technologies201314—
+2K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+2K123388K7C SpacerK7, LLC20130—
+2K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+2K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+2K122047Alamo PAlliance Partners, LLC20120—
+2K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+2K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+2K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+2K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+2K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology20124762
+2K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+2K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+2K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+2K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+2K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+2K113478Plif CageEisertech, LLC2012269—
+2K120024Mectalif TransforaminalMedacta International S.A.201223—
+2K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+2K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+2K113138Aleutian SystemK2m, Inc.2012549—
+2K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+2K112862Mecta-CMedacta International201114—
+2K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc.20115371
+2K113348Cougar SystemJohnson & Johnson2011591—
+2K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152—
+2K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—