510(k) Report

Devices descending from K984578

29 later devices reach Synergy D2 Spinal Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+1K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+1K142576Spinal SystemEisertech, LLC201511
+1K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+1K100757Tilock Pedicle Screw SystemGenesys Spine201091
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+2K252322SIros-X SystemGenesys Spine20250—
+2K240963Spinal SystemTeslake, Inc.20240—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+2K172469TiLock Modular Spinal SystemGenesys Spine20170—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K171838TiLock2 Spinal SystemGenesys Spine20174—
+2K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+2K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—