510(k) Report

Devices descending from K091134

10 later devices reach Custom Spine Regent Anterior Cervical Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141993Nakoma AcpAlliance Partners, LLC201481
+1K101151Regent Anterior Cervical PlateCustom Spine20100—
+2K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+2K201521Medina Anterior Cervical Plate SystemAlliance Partners, LLC20200—
+2K173128Alamo® CAlliance Partners, LLC20182—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—