510(k) Report

Devices descending from K033926

763 later devices reach Hourglass Vertebral Body Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K202637F3D Corpectomy SystemCorelink, LLC20201—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K1803473d CageFims Co., Ltd.20190—
+8K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+8K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+8K190680Favo S-TlifSilony Medical GmbH20190—
+8K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K212358Romero Cervical CageSpineup, Inc.20226—
+9K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+9K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+10K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K230026SqualeImplanet, S.A.20230—
+10K211306LabyrinthZavation Medical Products, LLC20213—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—