510(k) Report

Devices descending from K150600

16 later devices reach Response 5.5/6.0 Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+1K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+1K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+2K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+2K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+2K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—