510(k) Report

Devices descending from K070638

59 later devices reach Theken Atoll Cervico-Thoracic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+1K133214Blackbird Spinal SystemChoicespine, LP20143—
+1K092295Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology201024—
+1K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC200921—
+1K083073Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC20098—
+1K080790Modification to Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC20089—
+2K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+2K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+2K220025ARx® Spinal SystemLife Spine, Inc.20220—
+2K210887Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC20210—
+2K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+2K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+2K173047The Solstice OCT SystemLife Spine, Inc.20180—
+2K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC20124—
+2K120998Solstice Cross ConnectorLife Spine20121—
+2K112757Pioneer Posterior Cervico Thoracic SystemPioneer Surgical Technology, Inc.2012181
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+3K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+3K200896Solstice CCILife Spine, Inc.20200—
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+3K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+3K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K223852VySpan™ PCT SystemVy Spine, LLC20231—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K152211PCT SystemCentinel Spine, Inc.20150—
+4K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K232167VySpan™ PCT SystemVy Spine, LLC20230—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—