510(k) Report

Devices descending from K964159

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240963Spinal SystemTeslake, Inc.20240—
+7K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+7K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+7K150417Astra Spine SystemSpinecraft, LLC201521—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+8K211323ASTRA Spine SystemSpinecraft, LLC202112—
+8K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+8K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K172115Navigated Instrument SystemOrthofix, Inc.20184—
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+8K162786PASS LP Spinal SystemMedicrea International SA20176—
+8K161842Overwatch Spine SystemAmendia, Inc.201661
+8K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+9K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+9K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+9K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+9K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+9K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+9K182240PASS LP Spinal SystemMedicrea International SA20182—
+9K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+10K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K252322SIros-X SystemGenesys Spine20250—
+10K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+10K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+10K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+10K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K231658VEOS Spinal Fixation SystemSpineway20230—
+10K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+10K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+10K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+10K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+10K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+11K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+11K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+12K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+12K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—