510(k) Report

Devices descending from K152457

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K233366SYMPHONY OCT SystemMedos International SARL20230—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—