510(k) Report

Devices descending from K162494

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+1K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+1K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+1K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+1K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+2K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+2K253249TriALTIS™ Spine SystemMedos International SARL20251—
+2K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+2K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+2K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+2K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K231479TriALTIS Spine SystemMedos International SARL20238—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K243249TriALTIS™ Spine SystemMedos International SARL20250—
+4K233684TriALTIS™ Spine SystemMedos International SARL20234—
+5K242042TriALTIS™ Spine SystemMedos International SARL20241—