510(k) Report

Devices descending from K060152

32 later devices reach Modification to S4 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+1K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+1K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+1K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+1K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+2K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+2K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+2K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+2K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+2K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201513—
+3K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+3K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+3K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+3K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+4K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+4K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+4K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+4K203205Navigated Spine InstrumentsStryker Spine20218—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+5K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+5K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K260546Q Pedicle InstrumentsK2m, Inc.20260—
+6K252873Q Interbody InstrumentsK2m, Inc.20260—
+6K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+6K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+7K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+7K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+7K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—