ClearanceBrief
Panels › Orthopedic › Product code ODP · Class 2

Intervertebral Fusion Device With Bone Graft, Cervical

Regulation 888.3080

24510(k)s in 12 months (354 all time)
2recalls in 12 months (11 all time)
9recalls that name a 510(k)
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Top companies in ODP

Company510(k)sRecalls
Medtronic Sofamor Danek100
Orthofix100
Nu Vasive, Incorporated80
Gbs Commonwealth Co., Ltd.70
Globus Medical, Inc.70
Reliance Medical Systems, LLC60
Spineart60
Stryker Spine60
Innovasis, Inc.50
L&K BIOMED Co., Ltd.50
Decided510(k)Device and applicantCode
Jun 25, 2018K180674EVOL® ha-C Cervical Interbody Fusion System
Cutting Edge Spine, LLC
ODP
Jun 25, 2018K172788MONET™ Anterior Cervical Interbody Fusion Cage System
Ctl Medical Corporation
ODP
Jun 14, 2018K180401TiWAVE-C™ Porous Titanium Cervical Cage
Kalitec Direct, LLC
ODP
Jun 13, 2018K180675Atlas Spine Expandable Cervical Interbody System
Atlas Spine, Inc.
ODP
May 23, 2018K173722PATRIOT COLONIAL Spacer, SUSTAIN Spacer
Globus Medical, Inc.
ODP
May 17, 2018K173832InTice™-C Porous Ti Cervical Interbody System
X-Spine Systems, Inc.
ODP
May 17, 2018K172480icotec Interbody Cage System
Icotec AG, CH
ODP
May 4, 2018K172568Cervage
Precifit Medical, Ltd.
ODP
Mar 22, 2018K173128Alamo® C
Alliance Partners, LLC
ODP
Mar 5, 2018K173453Valeo® C+CSC with Lumen Interbody Fusion Device
Amedica Corp.
ODP
Feb 27, 2018K173324ALTA Anterior Cervical Interbody Spacer
Astura Medical
ODP
Feb 26, 2018K172320Neurostructures Cavetto® Cervical Cage System
Neurostructures, Inc.
ODP
Feb 13, 2018K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS
Titan Spine, LLC
ODP
Jan 9, 2018K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™
Ctl Medical Corporation
ODP
Jan 8, 2018K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device
4Web, Inc.
ODP
Dec 29, 2017K173102Reliance Cervical IBF System
Reliance Medical Systems, LLC
ODP
Dec 21, 2017K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical
SeaSpine Orthopedics Corporation
ODP
Dec 21, 2017K172185Tyber Medical PT Interbody Spacer System
Tyber Medical, LLC
ODP
Dec 20, 2017K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS
Globus Medical, Inc.
ODP
Dec 14, 2017K172676NuVasive® Modulus-C Interbody System
Nu Vasive, Incorporated
ODP
Dec 1, 2017K173148ACIF
Coligne AG, CH
ODP
Nov 21, 2017K173030Vertera Spine Cohere Cervical Interbody Fusion Device
Nu Vasive, Incorporated
ODP
Nov 21, 2017K172253Altus Spine Cervical Interbody Fusion System
Altus Partners, LLC
ODP
Nov 7, 2017K172446SPIRA-C Open Matrix Cervical Interbody
Camber Spine Technologies
ODP
Nov 2, 2017K172674Sapphire Cervical Implant System
Sapphire Medical Group
ODP
Nov 2, 2017K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
Orthofix, Inc.
ODP
Sep 29, 2017K172065SCARLET AC-T
Spineart, CH
ODP
Sep 18, 2017K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
Medacta International S.A., CH
ODP
Sep 18, 2017K163422Shanghai Sanyou PEEK Cage System
Shanghai Sanyou Medical Co, Ltd., CN
ODP
Sep 7, 2017K172489Reliance Cervical IBF System
Reliance Medical Systems, LLC
ODP
Sep 6, 2017K171496Tritanium C Anterior Cervical Cage
Stryker Spine
ODP
Aug 22, 2017K171140Matrixx System
Nexxt Spine, LLC
ODP
Aug 1, 2017K171075Calix-C Cervical Interbody Spacer
X-Spine Systems, Inc.
ODP
Jul 13, 2017K171749Velofix(tm) Interbody Fusion System
U&I Corporation, KR
ODP
Jul 13, 2017K170550Coveris Cervical Cage System
Camber Spine Technologies
ODP
Jul 12, 2017K170318NeoFuse Ti3D PLIF/TLIF/Cervical Interbody
Ht Medical, LLC
ODP
Jul 7, 2017K171046SeaSpine Cambria System
SeaSpine Orthopedics Corporation
ODP
Jul 3, 2017K170844Gemini-C Hybrid Cervical Interbody System
Osseus Fusion Systems, LLC
ODP
Jun 20, 2017K163494Summit Spine Channel Cervical Interbody Fusion System
Summit Spine
ODP
Jun 1, 2017K162682MATISSE Anterior Cervical Interbody Fusion Cage System
Ctl Medical Corporation
ODP
May 23, 2017K163673Fortilink™-C with TETRAfuse™ 3D Technology
Rti Surgical, Inc.
ODP
May 4, 2017K162496Foundation 3D Interbody
Corelink, LLC
ODP
Apr 7, 2017K163265Kepler II
Orbbo Surgical, LLC
ODP
Mar 24, 2017K163491NuVasive CoRoent Small Interbody System
Nu Vasive, Incorporated
ODP
Feb 16, 2017K1624024CIS® Marlin ACIF Cage System
Solco Biomedical Co., Ltd., KR
ODP
Jan 26, 2017K162587ROCCIA® ACIF
Silony Medical GmbH, DE
ODP
Jan 24, 2017K170074nvc
Nvision Biomedical Technologies, LLC
ODP
Jan 12, 2017K162694Ayers Rock Cervical interbody fusion system
Spineway, FR
ODP
Dec 22, 2016K161127The Small PLATEAU (PLATEAU-C) Spacer System
Life Spine, Inc.
ODP
Dec 21, 2016K162003IMSE Cervical Cage
The Institute of Musculoskeletal Science & Education
ODP

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