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
Aug 14, 2023K230607SPICCA Cervical Fusion Cages
Southern Medical (Pty) , Ltd., ZA
ODP
Jul 26, 2023K222874CarboClear Cervical Cage System, CarboClear Cervical VBR System
Carbofix Orthpedics , Ltd., IL
ODP
Jul 11, 2023K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Inter
Nu Vasive, Incorporated
ODP
Jul 5, 2023K222015Integral Titanium Cervical Interbody
Nvision Biomedical Technologies, Inc.
ODP
Jun 6, 2023K230329F3D Interbody System
Corelink, LLC
ODP
Jun 2, 2023K230936Anatomic PEEK™ Cervical Fusion System with Nanotechnology
Nanovis, LLC
ODP
May 22, 2023K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (Th
Gbs Commonwealth Co., Ltd., KR
ODP
May 19, 2023K222833Ventana™ C Spinal System
Spinal Elements, Inc.
ODP
May 12, 2023K230414ClariVy™ Cervical IBF System
Vy Spine, LLC
ODP
Apr 28, 2023K222004INTEGRATE -C Interbody Fusion System
Happe Spine
ODP
Apr 25, 2023K220513NITRO Interbody Fusion Cage System Family
Ctl Medical Corporation
ODP
Apr 24, 2023K220261NEST-C Interbody System
Paonan Biotech Co., Ltd., TW
ODP
Apr 18, 2023K223513UniVy™ OsteoVy™-Ti Cervical IBF System
Vy Spine, LLC
ODP
Mar 28, 2023K230026SQUALE
Implanet, S.A., FR
ODP
Mar 22, 2023K230583Tryptik Ti
Spineart SA, CH
ODP
Mar 20, 2023K223043The Integrity Spine Core System
Integrity Spine
ODP
Feb 24, 2023K223231Ti-Largo Cervical Interbody System
Flospine
ODP
Feb 17, 2023K213755Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
Gbs Commonwealth Co., Ltd., KR
ODP
Feb 14, 2023K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expanda
Stryker Spine
ODP
Feb 13, 2023K213030Curiteva Porous PEEK Cervical Interbody Fusion System
Curiteva, Inc.
ODP
Feb 6, 2023K212701Eminent Spine 3D Cervical Interbody Fusion System
Eminent Spine
ODP
Feb 3, 2023K220296Manta Ray TDF Spacer
SeaSpine Orthopedics Corporation
ODP
Jan 12, 2023K223731NuVasive Modulus-C Interbody System
Nuvasive, Inc.
ODP
Jan 5, 2023K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device
4Web Medical, Inc.
ODP
Dec 22, 2022K222806Kodiak C Spinal Implant System
Met One Technologies, LLC
ODP
Dec 12, 2022K223510Matrix HA Fusion Porous Cervical IBF System
Innovasis, Inc.
ODP
Nov 17, 2022K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Inter
Alphatec Spine, Inc.
ODP
Nov 4, 2022K221162UniVy OsteoVy Cervical IBF System
Vy Spine, LLC
ODP
Oct 21, 2022K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments
Globus Medical, Inc.
ODP
Oct 15, 2022K222276CONDUIT Cages; FIBERGRAFT BG Putty
Depuy Spine
ODP
Aug 26, 2022K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
Innovasis, Inc.
ODP
Aug 19, 2022K220696uCerv Flux-C 3D Porous Titanium Cervical Interbody
Ulrich Medical USA
ODP
Jun 6, 2022K212450Keos Anterior Cervical Interbody Fusion Device System
Keos
ODP
Mar 29, 2022K202266Reliance Cervical IBF System
Reliance Medical Systems, LLC
ODP
Mar 15, 2022K213980Peridot Spinal Interbody System
Gbs Commonwealth Co., Ltd., KR
ODP
Jan 27, 2022K213493Fortilink with TiPlus Technology
Paradigm Spine, DE
ODP
Dec 21, 2021K212266FIX-C PEEK Anterior Cervical Interbody System
Jeil Medical Corporation, KR
ODP
Dec 20, 2021K212715Vy Spine ClariVy Cervical IBF System
Vy Spine, LLC
ODP
Dec 6, 2021K213115CHENA-C Spacer System
Kahtnu Surgical, Inc.
ODP
Sep 30, 2021K211935ORIO-Ti Intervertebral Body Fusion Cage System
Spinecraft, LLC
ODP
Sep 23, 2021K212792Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
Medynus, Inc.
ODP
Sep 13, 2021K201793EDEN Peek Cage
Jmt Co., Ltd., KR
ODP
Aug 31, 2021K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer
Orthofix, Inc.
ODP
Aug 27, 2021K212038K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K&J Consulting Corporation
ODP
Aug 24, 2021K211501Advantage-C PEEK Cervical lnterbody Fusion Device
Lntelivation, LLC
ODP
Aug 2, 2021K210521DEXA-C Cervical Interbody System
Aurora Spine, Inc.
ODP
Apr 23, 2021K210890GPS Cervical Spacers
G Surgical, LLC
ODP
Apr 7, 2021K203520Blustone Synergy Interbody Fusion System
Blustone Synergy, LLC
ODP
Mar 18, 2021K203444BEE HA Cage
NGMedical GmbH, DE
ODP
Mar 18, 2021K203342CONSTRUX Mini Ti Spacer System
Orthofix, Inc.
ODP

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