510(k) Report

Devices descending from K110280

95 later devices reach Revlok Fenestrated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223273ASTRA Spine SystemSpinecraft, LLC20228—
+1K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+1K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+1K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+1K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+1K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+1K123717UcentumUlrich GmbH & Co. KG2013171
+2K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+2K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+2K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+2K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K151727Everest Spinal SystemK2m, Inc.201511—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K171321K2M Navigation InstrumentsK2m201711
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—