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

Decided510(k)Device and applicantCode
Feb 4, 2021K202872Prase PEEK Anterior Cervical Interbody Spacer
Gbs Commonwealth Co., Ltd., KR
ODP
Jan 29, 2021K202398Ti3Z Cervical Interbody System
Zavation Medical Products, LLC
ODP
Jan 29, 2021K200429BEE Cages
NGMedical GmbH, DE
ODP
Jan 7, 2021K202488ZSFab Cervical Interbody System
Zsfab, Inc.
ODP
Dec 28, 2020K200458Tailored-C Cervical Interbody Fusion System
Bespoke Technologies
ODP
Dec 22, 2020K201643ChoiceSpine Tiger Shark Cervical Spacer System
Choice Spine, LLC
ODP
Dec 16, 2020K200549Lucero Medical Cervical Cage System
Lucero Medical, LLC
ODP
Oct 30, 2020K202302Atlas Spine Rebar (Ti) Spacer System
Atlas Spine, Inc.
ODP
Oct 29, 2020K202949CONSTRUX Mini PEEK Spacer System
Orthofix, Inc.
ODP
Oct 14, 2020K202666CONSTRUX Mini PTC Spacer System
Orthofix, Inc.
ODP
Sep 11, 2020K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
Meditech Spine, LLC
ODP
Sep 3, 2020K201769Cavetto [MAX] Cervical Cage System
Neurostructures, Inc.
ODP
Aug 10, 2020K200592GS Medical AnyPlus PEEK Cage System
GS Medical Co., Ltd., KR
ODP
Jun 11, 2020K200685RIGEL 3DR Anterior Cervical Interbody Fusion System
MiRus, LLC
ODP
Apr 9, 2020K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System
Orthofix, Inc.
ODP
Apr 6, 2020K200312Tryptik Ti
Spineart, CH
ODP
Mar 20, 2020K192897icotec Cervical Cage
Icotec AG, CH
ODP
Jan 3, 2020K193359SureMAX Family of Cervical Spacers
Additive Implants, Inc.
ODP
Dec 19, 2019K1920444CIS Marlin PEEK ACIF Cage
Solco Biomedical Co., Ltd., KR
ODP
Oct 24, 2019K191812ADI Cervical Interbody Fusion Device
Additive Device, Inc. (Adi) D/B/A Restor3D
ODP
Oct 17, 2019K192316Matrix HA PEEK Cervical Implant System
Sapphire Medical Group
ODP
Oct 11, 2019K191822Nano FortiCore, FortiCore
Nanovis, LLC
ODP
Oct 9, 2019K192208CORNICE Cervical Spacer System
Legend Spine Technologies
ODP
Sep 26, 2019K191537eCarbon IBDs
Back 2 Basics Direct, LLC
ODP
Sep 17, 2019K191243HEDRON Cervical Spacers
Globus Medical, Inc.
ODP
Sep 9, 2019K191354Ti3Z Cervical Interbody System
Zavation Medical Products, LLC
ODP
Aug 16, 2019K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO
Titan Spine, Inc.
ODP
Aug 15, 2019K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine C
Choice Spine, LLC
ODP
Jul 30, 2019K190291Addivation Medical Cervical Interbody System
Addivation Medical, LLC
ODP
Jun 19, 2019K190889Republic Spine Restore Cervical Interbody Fusion System
Republic Spine, LLC
ODP
Jun 13, 2019K182608Oyster ACIF Cage
Silony Medical GmbH, DE
ODP
Jun 6, 2019K190618RIGEL PEEK Anterior Cervical Interbody Fusion System
MiRus, LLC
ODP
Mar 21, 2019K190380nvc
Nvision Biomedical Technologies, Inc.
ODP
Mar 6, 2019K183397ChoiceSpine Stealth Cervical Spacer System
Choicespine, LP
ODP
Mar 4, 2019K190322SCARLET® AC-T Secured Anterior Cervical Cage
Spineart, CH
ODP
Feb 14, 2019K183083Shoreline Cervical Interbody RT System
SeaSpine Orthopedics Corporation
ODP
Feb 11, 2019K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion D
Titan Spine, Inc.
ODP
Feb 4, 2019K190067Velofix Interbody Fusion System
U&I Corporation, KR
ODP
Jan 28, 2019K182477Cervical Spacer
Additive Implants, LLC
ODP
Jan 18, 2019K182284Tyber Medical PT Interbody Spacer
Tyber Medical, LLC
ODP
Dec 18, 2018K180909REVEL Spacers
Globus Medical, Inc.
ODP
Nov 16, 2018K181140Axis Chena Cervical PEEK Spacer System
Axis Orthopaedics
ODP
Nov 8, 2018K181590Neurostructures Cavetto® [MAX] Cervical Cage System
Neurostructures, Inc.
ODP
Sep 19, 2018K181229TirboLOX-C Cervical IBFD
Captiva Spine, Inc.
ODP
Aug 29, 2018K181471ACCUFUSE Cervical System
Absolute Advantage Medical, LLC
ODP
Aug 21, 2018K181435ATEC Cervical Spacer System
Alphatec Spine, Inc.
ODP
Jul 16, 2018K181115CxHA PEEK Cervical IBF System
Innovasis, Inc.
ODP
Jul 9, 2018K181261Curiteva Cervical Interbody Fusion System
Curiteva, LLC
ODP
Jul 6, 2018K180590Tyber Medical PT Interbody Spacer System
Tyber Medical, LLC
ODP
Jun 27, 2018K180364HD LifeSciences Cervical IBFD System
Hd Lifesciences, LLC
ODP

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