510(k) Report

Devices descending from K192492

10 later devices reach EL CAPITAN Anterior Lumber Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+1K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+2K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+2K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+2K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+2K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—