510(k) Report

Devices descending from K040366

23 later devices reach Pressure Manifold, Model BC 110 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110383Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical20110Class I
+1K091538Pressure Release Valve W/Audible, Model PRV 20/40/60; with T6 Adapter, Model PRV…Wet Nose Technologies, LLC20101—
+1K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+2K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+2K111191Audible Pressure Release Valve with Humidifier Adapter / and Oxygen NippleWet Nose Technologies, LLC20110—
+2K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+3K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+3K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+4K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+4K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+5K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+5K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+5K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+5K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+6K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+6K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+6K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—