510(k) Report

Devices descending from K994217

313 later devices reach Blackstone Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+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—