510(k) Report

Devices descending from K070962

118 later devices reach Coral Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120047Coral Spinal SystemTheken Spine, LLC201214—
+1K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+1K100970Stainless Steel Spinal SystemTheken Spine, LLC20101—
+1K091266Theken Coral Spinal SystemTheken Spine, LLC200915—
+1K081414Modification to Coral Spinal SystemTheken Spine, LLC200821—
+1K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+2K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+2K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+2K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K120829Stainless Steel Spinal SystemTheken Spine, LLC20120—
+2K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+2K080767Conquest Spinal SystemLife Spine200821—
+3K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K123373Nautilus Spinal SystemLife Spine201317—
+3K111953Nautilus Spinal SystemLife Spine20123—
+3K090320Conquest Spinal SystemLife Spine20092—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+4K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K171321K2M Navigation InstrumentsK2m201711
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—