510(k) Report

Devices descending from K070218

60 later devices reach Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102315Staxx XDL SystemSpine Wave, Inc.20113—
+1K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+2K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+2K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+2K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+2K133207Staxx (R) SystemSpine Wave, Inc.20131—
+2K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+3K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+3K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+3K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+5K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+7K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—