510(k) Report

Devices descending from K153589

10 later devices reach CD HORIZON Spinal System through their predicates, nearest generation first.

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