510(k) Report

Devices descending from K124012

6 later devices reach Infill Oblique Tlif Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+2K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—