510(k) Report

Devices descending from K211873

11 later devices reach PSX Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+1K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+2K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+2K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+2K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—