510(k) Report

Devices descending from K161014

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+1K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+1K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+1K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+2K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+2K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+2K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+2K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+3K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, 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—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+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—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—