510(k) Report

Devices descending from K031888

11 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+2K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+2K161842Overwatch Spine SystemAmendia, Inc.201661
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K173126Arisstos™ Spinal SystemIngenium Spine20171—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—