510(k) Report

Devices descending from K944736

598 later devices reach VSP (Variable Screw Placement) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243693NEO Pedicle Screw System™Neo Medical SA20240—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+9K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K233684TriALTIS™ Spine SystemMedos International SARL20234—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+9K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223494CD Horizon Spinal SystemMedtronic202317—
+9K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+9K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+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—
+9K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+9K190751Connector SystemOrthofix, Inc.20193—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+9K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+9K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+9K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+9K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+9K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+9K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+9K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+10K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K242042TriALTIS™ Spine SystemMedos International SARL20241—
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+10K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+10K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+10K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+10K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+10K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+10K182470Plateau Spacer SystemLife Spine20180—
+10K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K233366SYMPHONY OCT SystemMedos International SARL20230—
+11K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+11K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+11K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+11K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+11K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+12K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+12K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+13K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+13K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+13K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—