510(k) Report

Devices descending from K043066

27 later devices reach Pioneer Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+1K083663PACPPioneer Surgical Technology200917—
+1K073500Active Anterior Cervical Plate SystemSanacor20080—
+1K053053Pacp SystemPioneer Surgical Technology200525—
+2K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+2K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+2K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+2K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+2K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+3K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+3K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+3K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+3K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+3K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+3K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+4K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+4K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+4K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+4K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+4K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+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—
+5K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+5K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—