510(k) Report

Devices descending from K151224

23 later devices reach Lineum OCT Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172594Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.201712—
+1K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+2K193129Yukon OCT Spinal SystemK2m, Inc.202001
+2K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+2K182182YUKON OCT Spinal SystemK2m20185—
+2K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+2K181440Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.20184—
+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—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+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—
+4K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+6K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+7K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—