510(k) Report

Devices descending from K925812

51 later devices reach Titanium Songer Cable System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071271Biomet Cable SystemBiomet Manufacturing, Inc.20070—
+1K974020Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc.199749—
+2K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc.201423—
+2K060009Abbott Spine Universal Clamp SystemAbbott Spine, Inc.200648—
+3K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+3K200281The Gecko Spinal SystemOrtho Development Corporation20200—
+3K160698LigaPASSMedicrea International SA201612—
+3K161267Response BandLoc Spinal FixationOrthoPediatrics Corp.201611
+3K161265NuVasive® VersaTie SystemNu Vasive, Incorporated20163—
+3K151740JAZZ SystemImplanet, S.A.201512—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+3K121541Jazz SystemImplanet, S.A.201227—
+3K112736Pass LP SpinalMedicrea International201225—
+3K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+3K081622Universal Clamp Stainless Steel SystemAbbott Spine, Inc.200846—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+4K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA20222—
+4K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.20200—
+4K172206NAJA™ Ligament Correction SystemCousin Biotech Sas20182—
+4K173117NuVasive® VersaTie™ SystemNuvasive, Inc.20172—
+4K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+4K172021LigaPASSMedicrea International SA201711—
+4K171881JAZZ Passer BandImplanet, S.A.20170—
+4K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+4K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+4K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+4K162764Jazz Frame SystemImplanet, S.A.20176—
+4K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K143759JAZZ SystemImplanet, S.A.201513—
+4K133617Jazz SystemImplanet, S.A.201414—
+4K132395LigapassMedicrea International201323—
+4K132287Jazz SystemHogan Lovells US LLP201315—
+4K091190Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063Zimmer Spine, Inc.200945—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K191217Jazz PFImplanet, S.A.20190—
+5K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated20190—
+5K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+5K173506LigaPASSMedicrea International SA20189—
+6K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—