510(k) Report

Devices descending from K091531

361 later devices reach Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+8K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+8K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+9K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—