510(k) Report

Devices descending from K133518

25 later devices reach Maxan Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+1K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+1K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+1K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.20201—
+1K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+1K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+1K173306EZ PlateZavation Medical Products, LLC20180—
+1K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+1K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA20160—
+1K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20160—
+1K150700ACP 1 Anterior Cervical Plating SystemStryker Corporation20150—
+1K150666uNion Cervical Plate SystemUlrich Medical USA201531
+2K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+2K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+2K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+2K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+2K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+2K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+2K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+3K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—