510(k) Report

Devices descending from K153631

18 later devices reach Zimmer Virage OCT Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250332Virage® OCT Spinal Fixation SystemHighridge Medical, LLC20250—
+1K220132FIREFLY® Cervical Navigation GuideMighty Oak Medical, Inc.20221—
+1K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+1K201481Centurion POCT SystemOrthofix, Inc.20203—
+1K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+1K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+1K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+1K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+1K171834G Surgical OCT Spinal SystemG Surgical, LLC20170—
+1K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+2K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+2K231515MySpine Cervical GuidesMedacta International S.A.20230—
+2K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+2K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+2K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—