510(k) Report

Devices descending from K111553

14 later devices reach Spinefrontier Lumbar Ibf System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+1K142504SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc.20154—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K193106SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc.20200—
+2K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+2K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+2K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+2K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K183243Velofix TLIF CageU&I Corporation20190—