510(k) Report

Devices descending from K190483

9 later devices reach SPIRA Open Matrix ALIF and LLIF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+1K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+1K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+1K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+2K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+2K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+2K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+2K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+2K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—