510(k) Report

Devices descending from K180502

11 later devices reach S128 Anterior Lumbar Interbody Fusion (ALIF) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+1K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+1K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+1K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+2K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+2K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+2K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+2K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+2K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—