510(k) Report

Devices descending from K110906

103 later devices reach Apex Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—