510(k) Report

Devices descending from K003275

1,705 later devices reach Synthes Synmesh Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+6K171312FortiCore®Nanovis, LLC20183—
+6K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+6K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+6K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K172009Cascadia Interbody SystemK2m, Inc.2017433
+6K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K163595IMPIX 3D Print CagesMedicrea International SA2017282
+6K172083Idys™ ALIF SystemClariance, Sas20177—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+6K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+6K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+6K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+6K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+6K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+6K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+6K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+6K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+6K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K153665Prow Fusion-LNlt Spine, Ltd.20160—
+6K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K153786Prow Fusion-VNlt Spine, Ltd.20166—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+6K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+6K160125Cascadia Interbody SystemK2m2016315—
+6K160547Cascadia Interbody SystemK2m2016157—
+6K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+6K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+6K151939COALITION SpacersGlobus Medical, Inc.2016152—
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+6K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+6K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+6K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+6K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+6K150481Cascadia Interbody SystemK2m, Inc.20154593
+6K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+6K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+6K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+6K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+6K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+6K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K142487Chesapeake Stabilization SystemK2m, Inc.201571
+6K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+6K142392Zavation Posterior LEIFZavation, LLC20150—
+6K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+6K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+6K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+6K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+6K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+6K142271Zavation Z-Link LumbarZavation, LLC20149—
+6K141135Juliet LLSpineart2014146—
+6K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+6K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+6K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+6K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—