510(k) Report

Devices descending from K160989

67 later devices reach NuVasive® Reline® System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+1K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+1K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+1K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+2K191575ARx Spinal SystemLife Spine, Inc.201910—
+2K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+3K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—