510(k) Report

Devices descending from K153370

17 later devices reach Caspian OCT/MESA Mini/DENALI Mini Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+1K182182YUKON OCT Spinal SystemK2m20185—
+1K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+1K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+2K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K193129Yukon OCT Spinal SystemK2m, Inc.202001
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—