510(k) Report

Devices descending from K041592

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K171321K2M Navigation InstrumentsK2m201711
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—