510(k) Report

Devices descending from K130254

8 later devices reach Prow Fusion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153665Prow Fusion-LNlt Spine, Ltd.20160—
+1K151654Prow FusionNlt Spine, Ltd.20151—
+1K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+3K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—