510(k) Report

Devices descending from K041592

261 later devices reach Coral Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120047Coral Spinal SystemTheken Spine, LLC201214—
+1K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+1K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+1K100970Stainless Steel Spinal SystemTheken Spine, LLC20101—
+1K091266Theken Coral Spinal SystemTheken Spine, LLC200915—
+1K081414Modification to Coral Spinal SystemTheken Spine, LLC200821—
+1K072407Bodyform Thoracic Fixation SystemTheken Spine, LLC200787—
+1K070962Coral Pedicle Screw SystemTheken Spine, LLC2007118—
+2K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+2K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+2K200885Meridian Anterior Plate System, Regatta Lateral Plate SystemSeaSpine Orthopedics Corporation202012—
+2K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+2K120829Stainless Steel Spinal SystemTheken Spine, LLC20120—
+2K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+2K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc.200973—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K182721Choice Spine Navigation SystemChoicespine, LP20192—
+3K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+3K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K131533Cayman MI Plate SystemK2m, Inc.201372—
+3K123717UcentumUlrich GmbH & Co. KG2013171
+3K080767Conquest Spinal SystemLife Spine200821—
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K190016Lateral Plate SystemCorelink, LLC201915—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K090320Conquest Spinal SystemLife Spine20092—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—