510(k) Report

Devices descending from K042635

115 later devices reach Denali Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—