510(k) Report

Devices descending from K982990

776 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+9K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+9K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+9K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+9K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+9K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+9K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+9K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+9K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+9K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+9K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+9K203816DeGen Navigated InstrumentationDegen Medical20211—
+9K210472SPINEART Navigation Instrument SystemSpineart20215—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+9K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+9K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+9K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+9K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+9K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+9K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+9K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+9K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+9K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+9K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K191217Jazz PFImplanet, S.A.20190—
+9K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+9K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+9K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+9K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+9K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+9K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+9K171881JAZZ Passer BandImplanet, S.A.20170—
+9K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+9K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+9K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+9K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+9K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+9K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+9K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+10K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+10K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+10K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+10K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+10K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+10K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+10K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+10K242042TriALTIS™ Spine SystemMedos International SARL20241—
+10K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+10K233300POWEReam 1/4 DriveStryker Instruments20231—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+10K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+10K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+10K223294SpineJack® Expansion KitStryker Instruments20221—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+10K213918DeGen Navigated InstrumentationDegen Medical20220—
+10K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+10K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+10K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+10K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+10K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+11K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+11K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+11K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+11K250637VCFix Spinal SystemAmber Implants20250—
+11K240526POWEReam Xia/SerratoStryker Instruments20240—
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+11K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+11K182470Plateau Spacer SystemLife Spine20180—
+12K230989Rod Registration FrameNu Vasive, Incorporated20230—