510(k) Report

Devices descending from K062012

27 later devices reach S4 Cervical Occipital Plate Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+1K100147S4 Cervical Occipital Plate Spinal SystemAesculap Implant System, Inc.201024—
+2K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+2K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+2K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC201252
+3K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+3K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc.20190—
+3K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+3K123297Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp.20121—
+4K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—