510(k) Report

Devices descending from K170675

11 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—
+1K210997PreferX Delivery SystemMd3, LLC20210—
+1K2004313D GraftRasp SystemSurgentec20201—
+1K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+1K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+2K2019003D GraftRasp SystemSurgentec20200—
+2K201338Allograft MIS Delivery SystemLifenet Health20202—
+3K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+4K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—