510(k) Report

Devices descending from K010249

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+9K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+9K231658VEOS Spinal Fixation SystemSpineway20230—
+9K223273ASTRA Spine SystemSpinecraft, LLC20228—
+9K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+9K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+9K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+9K210549ARx Spinal SystemLife Spine, Inc.20211—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+9K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+9K190751Connector SystemOrthofix, Inc.20193—
+9K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+10K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+10K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+11K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+11K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K252322SIros-X SystemGenesys Spine20250—
+11K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+11K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+11K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+12K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—