510(k) Report

Devices descending from K072981

546 later devices reach Synthes Zero-P through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+1K172424Velofix™ SA Cervical CageU&I Corporation201751
+1K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+1K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+1K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+1K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+1K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+1K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+1K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+1K100698STCCCardinal Spine, LLC2011346—
+1K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+1K093762Synthes Zero-PSynthes Spine20103061
+1K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+1K092521ZUMA-CSeaspine, Inc.2010168—
+2K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+2K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+2K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+2K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+2K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+2K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+2K210573Velofix SA Cervical CageU&I Corporation20211—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K192906Mecta-C Stand AloneMedacta International S.A.20201—
+2K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+2K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+2K180695FBC 921 (Alif)Fbc Device Aps20180—
+2K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+2K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+2K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+2K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+2K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+2K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+2K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+2K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+2K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+2K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+2K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+2K131449Coalition SpacerGlobus Medical, Inc.2013235—
+2K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+2K112862Mecta-CMedacta International201114—
+2K111272Rhausler Plage Anterior Cervical Fusion SystemRhausler, Inc.20117—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+3K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K242303MOD-COrthomod, LLC20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+3K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+3K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+3K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+3K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+3K240715Idys® C ZP 3DTiClariance20240—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+3K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+3K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+3K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—