510(k) Report

Devices descending from K971883

531 later devices reach Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+6K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+6K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+6K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—