510(k) Report

Devices descending from K180937

6 later devices reach Graftgun Universal Graft Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC20260—
+1K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC20251—
+1K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+1K201338Allograft MIS Delivery SystemLifenet Health20202—
+2K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+3K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—