510(k) Report

Devices descending from K072703

19 later devices reach Pioneer Slimfuse Anterior Cervical Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+1K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+2K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+2K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+2K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+2K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+3K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+3K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+4K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+4K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+4K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+4K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+5K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+5K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+5K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—