510(k) Report

Devices descending from K011508

714 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+10K232628VADER® Pedicle SystemIcotec AG20241—
+10K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+10K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+10K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+10K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+10K190751Connector SystemOrthofix, Inc.20193—
+10K182182YUKON OCT Spinal SystemK2m20185—
+10K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+11K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+11K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+11K193129Yukon OCT Spinal SystemK2m, Inc.202001