510(k) Report

Devices descending from K231438

7 later devices reach Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System through their predicates, nearest generation first.

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