510(k) Report

Devices descending from K003709

1,714 later devices reach Surgical Dynamics Mesh Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K152568C-VBRCardinal Spine, LLC201657—
+5K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+5K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+5K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+5K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+5K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+5K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+5K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+5K143143Pathway ElifCustom Spine, Inc.201514—
+5K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+5K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+5K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+5K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+5K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+5K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+5K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+5K142744Mecta-C TiPEEKMedacta International201512—
+5K142392Zavation Posterior LEIFZavation, LLC20150—
+5K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+5K140348Interbody CageEisertech, LLC2015235—
+5K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+5K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+5K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+5K142271Zavation Z-Link LumbarZavation, LLC20149—
+5K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+5K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+5K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+5K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+5K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+5K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+5K141791Biomet Fusion SystemBiomet Spine2014128—
+5K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+5K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+5K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+5K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+5K133893Sterispine LC CageSafe Orthopaedics20141—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+5K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+5K133967Interbody Cage SystemAurora Spine2014227—
+5K133192Mectalif TipeekMedacta International201416—
+5K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+5K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+5K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+5K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+5K130254Prow FusionNlt Spine, Ltd.20138—
+5K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+5K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+5K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+5K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+5K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+5K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+5K131547Lanx Fusion SystemLanx, Inc.20131631
+5K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+5K124034Mectalif AnteriorMedacta International201311—
+5K123913Latis SpacerGlobus Medical, Inc.201388—
+5K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+5K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+5K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+5K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+5K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+5K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K122097Patriot SpacersGlobus Medical, Inc.2012261—
+5K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+5K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+5K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+5K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+5K122047Alamo PAlliance Partners, LLC20120—
+5K120819Stalif CCentinel Spine, Inc.2012206—
+5K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+5K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+5K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+5K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+5K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+5K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+5K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+5K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+5K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+5K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+5K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+5K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—