510(k) Report

Devices descending from K022605

302 later devices reach Blackstone Spinal Fixation System Staple & Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+13K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—