510(k) Report

Devices descending from K030625

109 later devices reach Spinal Concepts Inc. Pathfinder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—