510(k) Report

Devices descending from K160879

106 later devices reach CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+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—
+5K232628VADER® Pedicle SystemIcotec AG20241—