510(k) Report

Devices descending from K983622

328 later devices reach Bodyform Thoraco-Lumbar Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+10K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+10K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+10K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+10K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+10K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+10K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+10K181188EVEREST Spinal SystemK2m, Inc.20186—
+10K180376K2M Patient Specific RodsK2m, Inc.20182—
+10K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+11K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+11K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+11K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+11K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+11K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+11K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+11K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+11K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+11K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+11K151727Everest Spinal SystemK2m, Inc.201511—
+12K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+12K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+12K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+12K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+12K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+12K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—