510(k) Report

Devices descending from K022997

13 later devices reach Spectrum Cervical Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173935Mediant Anterior Cervical Plating SystemIntelligent Implant Systems, LLC20180—
+1K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC2010101
+1K050804Modification to: Spectrumtm Cervical Spinal SystemAesculap, Inc.200511—
+2K141993Nakoma AcpAlliance Partners, LLC201481
+2K121801Quintex Cervical Plating SystemAesculap Implant Systems, LLC20120—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K201521Medina Anterior Cervical Plate SystemAlliance Partners, LLC20200—
+3K173128Alamo® CAlliance Partners, LLC20182—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—