510(k) Report

Devices descending from K131350

21 later devices reach Calix Lumbar Spinal Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+1K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+1K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+2K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—