510(k) Report

Devices descending from K121733

21 later devices reach Infill Intervertebral Body Fusion 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—
+1K130461Stalif XCentinel Spine, Inc.201313—
+1K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+2K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+2K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+3K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—