510(k) Report

Devices descending from K170126

39 later devices reach NuVasive® Reline® 4.5-5.0 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+1K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+1K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+2K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+2K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+2K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+2K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+2K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+2K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+3K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+4K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—