510(k) Report

Devices descending from K110522

106 later devices reach Vertex Reconstruction System, Vertex Select Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—