510(k) Report

Devices descending from K011037

1,374 later devices reach Vertebral Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+3K141798Sypher Spacer SystemBiogennix, LLC20151—
+3K142271Zavation Z-Link LumbarZavation, LLC20149—
+3K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+3K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+3K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+3K133207Staxx (R) SystemSpine Wave, Inc.20131—
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+3K131449Coalition SpacerGlobus Medical, Inc.2013235—
+3K124034Mectalif AnteriorMedacta International201311—
+3K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+3K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+3K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+3K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+3K112862Mecta-CMedacta International201114—
+3K111272Rhausler Plage Anterior Cervical Fusion SystemRhausler, Inc.20117—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+3K110843Aleutian Spacer SystemK2m, Inc.2011589—
+3K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+3K103666Lanx LateralLanx, Inc.2011238—
+3K102738Lanx Fusion SystemLanx, LLC20113281
+3K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+3K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+3K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+3K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC2010113—
+3K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+3K082698Aleutian Ibf SystemK2m, Inc.2009662—
+3K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+3K081888Dynamik Intervertebral Body Fusion DeviceSpineart2009282—
+3K081196Spinal Usa VBR SystemSpinal USA200813—
+3K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+3K081636Peek-Optima Alif SpacerBiomet Spine2008542—
+3K081395Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine2008854—
+3K080673Interfuse Intervertebral Body Fusion DeviceVertebral Technologies, Inc.2008103—
+3K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+3K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+3K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+3K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine20081,102—
+3K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+3K063399Aleutian Spacer SystemK2m, Inc.2007663—
+3K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+4K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+4K240715Idys® C ZP 3DTiClariance20240—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—