510(k) Report

Devices descending from K150474

26 later devices reach NuVasive VuePoint II OCT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+1K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+1K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+1K153336VuePoint OCT SystemNu Vasive, Incorporated20162—
+2K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+2K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+2K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+2K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+2K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+2K182182YUKON OCT Spinal SystemK2m20185—
+2K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—