510(k) Report

Devices descending from K131374

22 later devices reach Tempus (TM) Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+1K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+1K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+1K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+2K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+2K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+2K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+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—
+3K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+3K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+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—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+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—
+6K262149corra® cervical plating systemCarlsmed, Inc.20260—