510(k) Report

Devices descending from K103393

104 later devices reach Polaris 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—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—