510(k) Report

Devices descending from K001319

695 later devices reach Xia Spine System Hooks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K162367Erisma® LP MISClariance, Sas20162—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+7K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+7K103292Trio Trauma Spinal SystemStryker Corporation201185—
+8K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+8K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+8K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+9K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+9K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+9K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+9K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K250637VCFix Spinal SystemAmber Implants20250—
+10K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+10K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+11K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+12K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+12K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+12K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—