510(k) Report

Devices descending from K192818

8 later devices reach Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal… 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—
+1K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+2K223294SpineJack® Expansion KitStryker Instruments20221—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K250637VCFix Spinal SystemAmber Implants20250—
+3K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—