510(k) Report

Devices descending from K043020

108 later devices reach Glaxy 3.2 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+10K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+11K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—