510(k) Report

Devices descending from K151216

11 later devices reach Everest Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173508Everest Spinal SystemK2m20189—
+1K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+2K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—