510(k) Report

Devices descending from K190636

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+1K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+2K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+3K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+3K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+3K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+3K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—