510(k) Report

Devices descending from K013558

304 later devices reach Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—