510(k) Report

Devices descending from K112648

14 later devices reach Asfora Bullet Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+1K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+1K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—