510(k) Report

Devices descending from K922543

640 later devices reach Z-Plate Anterior Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+8K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+8K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K201585Monterey AL Interbody SystemStryker Corporation202044
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+8K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K171321K2M Navigation InstrumentsK2m201711
+8K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+8K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+8K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+8K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+8K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+9K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+9K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+9K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+9K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+9K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+9K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+9K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+9K182470Plateau Spacer SystemLife Spine20180—