510(k) Report

Devices descending from K190360

13 later devices reach LineSider™ Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+1K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+1K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+1K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+1K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+2K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—