510(k) Report

Devices descending from K022563

24 later devices reach Hydrocel Vertebral Body Replacement, Model 06-172-00XX1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051978Trabecular Metal Vertebral Body ReplacementImplex Corp.200522—
+1K051196Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1Implex Corp.200523—
+2K052950The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular200521—
+3K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+4K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+5K172424Velofix™ SA Cervical CageU&I Corporation201751
+5K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+6K210573Velofix SA Cervical CageU&I Corporation20211—
+6K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+6K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+7K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+7K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+7K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+7K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+8K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+8K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—