510(k) Report

Devices descending from K181390

13 later devices reach Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine… through their predicates, nearest generation first.

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