510(k) Report

Devices descending from K033844

91 later devices reach Synthes Anterior Cervical Compression System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+1K050451Synthes Vectra SystemSynthes Spine Co.Lp2005843
+2K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+2K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+2K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart20180—
+2K140361Meta-C Cervical PlateMedacta International20140—
+2K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+2K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+2K071667Synthes Vectra-One SystemSynthes Spine2007263
+2K061147Opteryx Anterior Cervical Plate SystemInnovasis, Inc.200611
+2K051665Synthes Vectra-T SystemSynthes Spine2005492
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+3K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+3K192049Oryx Cervical Plate SystemInnovasis, Inc.201901
+3K152239Zero-P Natural Plate SystemSynthes (Usa), LLC20150—
+3K143576Exactech AmbassadorExactech, Inc.201571
+3K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+3K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+3K130030Zavation Cervical Plate SystemZavation, LLC201315—
+3K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+3K112748Slimplicity Solo Anterior Cervical Plate SystemSpinal USA, LLC20120—
+3K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210—
+3K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc.20111—
+3K073500Active Anterior Cervical Plate SystemSanacor20080—
+4K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+4K200170SpineNet SSP SystemSpinenet, LLC20200—
+4K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+4K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+4K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+4K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics20181—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+4K152455Amendia Cervical Plate SystemAmendia, Inc.20151—
+4K150666uNion Cervical Plate SystemUlrich Medical USA201531
+4K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+4K141005Z-Link CervicalZavation, LLC20144—
+4K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.20145—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K243369Cervical Plating SystemLife Spine, Inc.20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+5K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K203154KASILOF Cervical Plate SystemKahtnu Surgical, Inc.20200—
+5K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+5K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+6K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+7K230026SqualeImplanet, S.A.20230—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+8K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K221172FOCUS Interbody SystemOc Medical Devices20220—