510(k) Report

Devices descending from K024364

1,683 later devices reach Synthes Vertebral Spacer TI (Curved and Narrow) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K133402K2M Modular HooksK2m, Inc.20140—
+8K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+8K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+8K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+8K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+8K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+8K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+8K130461Stalif XCentinel Spine, Inc.201313—
+8K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+8K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+8K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+8K120869Anchor-L Lumbar CageStryker Spine2012638—
+8K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+8K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+8K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+8K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+8K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+8K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+8K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+8K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+8K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+8K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+8K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+8K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+8K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+8K103369Vault Alif SystemSpinal USA201110—
+8K093093Small Plateau Spacer SystemLife Spine2010393—
+8K101301Stalif MidlineCentinel Spine2010474—
+8K083475Lucent MagnumSpinal Elements, Inc.2009834—
+8K081711Lucent Magnum+Spinal Elements, Inc.20080—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+9K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+9K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+9K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K201793EDEN Peek CageJmt Co., Ltd.20210—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+9K193174Keos Lumbar IBFDKeos20190—
+9K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+9K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+9K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+9K182721Choice Spine Navigation SystemChoicespine, LP20192—
+9K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+9K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+9K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+9K171321K2M Navigation InstrumentsK2m201711
+9K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+9K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+9K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+9K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+9K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+9K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+9K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+9K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+9K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+9K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+9K152651AccuLIF TL and PL CageStryker Corporation201530—
+9K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+9K152304Tritanium PL CageStryker20154481
+9K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—