510(k) Report

Devices descending from K152651

30 later devices reach AccuLIF TL and PL Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181397DualXInnovasive, Inc.201815—
+1K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+1K160715AccuLIF TL and PL CageStryker Corporation20160—
+2K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+2K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+2K211740DualXAmplify Surgical, Inc.20211—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+2K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+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—