510(k) Report

Devices descending from K162676

3 later devices reach Voyant Open Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180699Voyant Open Fusion DeviceApplied Medical Resources Corporation20182—
+2K201212Voyant Open Fusion DeviceApplied Medical Resources Corp.20201—
+3K252740Voyant® Open Fusion Device (EB240/Open Fusion)Applied Medical Resources Corp.20250—