510(k) Report

Devices descending from K000319

700 later devices reach Ebi Xfix DFS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+8K151216Everest Spinal SystemK2m, Inc.201511—
+8K142798PASS LP Spinal SystemMedicrea International SA201584—
+8K150049PASS LP Spinal SystemMedicrea International20150—
+8K141398Pass LP Spinal SystemMedicrea International SA2015101
+8K140738Pass LP Spinal SystemMedicrea International201447—
+8K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K132574Pass LP Spinal SystemMedicrea International20130—
+8K132575Pass LP Spinal SystemMedicrea International20130—
+9K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+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—
+9K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+9K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K231658VEOS Spinal Fixation SystemSpineway20230—
+9K230026SqualeImplanet, S.A.20230—
+9K223273ASTRA Spine SystemSpinecraft, LLC20228—
+9K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+9K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+9K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+9K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+9K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+9K202771CD Horizon Spinal SystemMedtronic202021—
+9K190751Connector SystemOrthofix, Inc.20193—
+9K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+9K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+9K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+9K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+9K160640PASS XS Spinal SystemMedicrea International SA20160—
+9K161627PASS LP Spinal SystemMedicrea International SA20167—
+10K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+10K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+10K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+10K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+10K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+10K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+10K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+10K211323ASTRA Spine SystemSpinecraft, LLC202112—
+10K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+10K210306GII Spinal Fixation SystemColigne AG20210—
+10K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+10K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+10K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+10K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+10K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+10K162786PASS LP Spinal SystemMedicrea International SA20176—
+11K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+11K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+11K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+11K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+11K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+11K252322SIros-X SystemGenesys Spine20250—
+11K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+11K233366SYMPHONY OCT SystemMedos International SARL20230—
+11K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+11K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+11K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+11K182240PASS LP Spinal SystemMedicrea International SA20182—
+12K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+12K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+12K190376PASS LP Spinal SystemMedicrea International SA201915