510(k) Report

Devices descending from K062004

64 later devices reach Modification to Quantum Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+1K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+2K102315Staxx XDL SystemSpine Wave, Inc.20113—
+2K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+2K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+2K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+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—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+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—
+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—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+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—
+6K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+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—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—