510(k) Report

Devices descending from K172816

59 later devices reach TiGer Shark™ System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+1K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+1K213417Ghost Spacer SystemLife Spine, Inc.20220—
+1K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+1K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+1K201671A-Link ZAcuity Surgical Devices, LLC202125—
+1K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+1K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+1K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+2K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+2K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+2K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+2K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+2K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+2K223418DeGen Impulse AM™ SystemDegen Medical20236—
+2K222561AlignAcuity Surgical Devices, LLC202214—
+2K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+2K220610SOLO-LAurora Spine, Inc.20220—
+2K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+2K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+3K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+3K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+3K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+3K232432E3D™-A Interbody SystemEvolution Spine20248—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—