510(k) Report

Devices descending from K050861

224 later devices reach Peek Cas through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+1K091381Ibex Spinal SystemEbi, L.P.2009181—
+1K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+2K102315Staxx XDL SystemSpine Wave, Inc.20113—
+2K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+2K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+3K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+3K133207Staxx (R) SystemSpine Wave, Inc.20131—
+3K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+3K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+4K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+4K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+6K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201585Monterey AL Interbody SystemStryker Corporation202044
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200312Tryptik TiSpineart20202—
+6K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+6K191134IB3D AlifMedicrea International SA20191—
+6K1803473d CageFims Co., Ltd.20190—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223326Axiom PSR SystemRestor3D202301