510(k) Report

Devices descending from K122845

28 later devices reach ES2 Spinal System Model 48280XXXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+1K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+1K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+1K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+1K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+1K162367Erisma® LP MISClariance, Sas20162—
+1K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+2K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+2K233300POWEReam 1/4 DriveStryker Instruments20231—
+2K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+2K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+2K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+2K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+2K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+2K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K240526POWEReam Xia/SerratoStryker Instruments20240—
+3K223294SpineJack® Expansion KitStryker Instruments20221—
+3K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+3K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+3K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K250637VCFix Spinal SystemAmber Implants20250—
+4K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+4K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+4K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+4K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—