510(k) Report

Devices descending from K132790

28 later devices reach Infix Anterior Lumbar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+1K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+1K180695FBC 921 (Alif)Fbc Device Aps20180—
+1K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+1K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+2K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+2K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—