510(k) Report

Devices descending from K133784

29 later devices reach Vista-S Device, Associated Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+1K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+1K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+2K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+2K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+2K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—