510(k) Report

Devices descending from K121541

27 later devices reach Jazz System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143759JAZZ SystemImplanet, S.A.201513—
+1K143350Nile Alternative FixationK2m, Inc.201510—
+1K133617Jazz SystemImplanet, S.A.201414—
+1K132287Jazz SystemHogan Lovells US LLP201315—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+2K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+2K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+2K151740JAZZ SystemImplanet, S.A.201512—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+3K171881JAZZ Passer BandImplanet, S.A.20170—
+3K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+3K162764Jazz Frame SystemImplanet, S.A.20176—
+3K161265NuVasive® VersaTie SystemNu Vasive, Incorporated20163—
+3K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+4K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+4K173117NuVasive® VersaTie™ SystemNuvasive, Inc.20172—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K191217Jazz PFImplanet, S.A.20190—
+5K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated20190—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—