510(k) Report

Devices descending from K032368

19 later devices reach Sonoma Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170342Ocata Anterior Cervical SystemKalitec Direct, LLC20171—
+1K112206Cardiff Anterior Cervical Plate SystemSeaspine, Inc.201215—
+1K083338Cardiff Anterior Cervical Plate SystemSeaspine, Inc.200916—
+2K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+2K172086Matira™ Anterior Cervical SystemKalitec Direct, LLC20170—
+3K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K254182AsterOsteonic Co., Ltd.20260—
+4K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K262149corra® cervical plating systemCarlsmed, Inc.20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—