ClearanceBrief
Panels › Orthopedic › Product code MAX · Class 2

Intervertebral Fusion Device With Bone Graft, Lumbar

Regulation 888.3080

20510(k)s in 12 months (897 all time)
5recalls in 12 months (116 all time)
105recalls that name a 510(k)
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Top companies in MAX

Company510(k)sRecalls
Medtronic Sofamor Danek5512
Globus Medical, Inc.2022
Nu Vasive, Incorporated340
Life Spine330
Alphatec Spine223
Spineology, Inc.220
SeaSpine Orthopedics Corporation201
Spinal Elements172
Stryker170
K2m133
Decided510(k)Device and applicantCode
Jun 9, 2023K231359RODIN™ Expandable Lumbar Cage System
Ctl Medical Corporation
MAX
May 26, 2023K230851Kodiak Lumbar Spacer System
Met One Technologies, LLC
MAX
May 19, 2023K231140aprevo® transforaminal lumbar interbody fusion device
Carlsmed, Inc.
MAX
May 16, 2023K230219Eminent Spine 3D Lumbar Interbody Fusion Systems
Eminent Spine, LLC
MAX
May 9, 2023K223335SIRION Lateral Lumbar Interbody System
Astura Medical
MAX
May 4, 2023K223430ProLift Micro Expandable Spacer System
Life Spine, Inc.
MAX
Apr 26, 2023K223868PYXIS 3D Titanium Cage System
GS Medical Co., Ltd., KR
MAX
Mar 29, 2023K223611Calibrate LTX Interbody System
Alphatec Spine, Inc.
MAX
Mar 17, 2023K223418DeGen Impulse AM™ System
Degen Medical
MAX
Mar 8, 2023K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments
Medos International Sàrl, CH
MAX
Mar 3, 2023K223776PEEK Spinal Infusion Cage
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd., CN
MAX
Feb 14, 2023K223174X-Pac Expandable LLIF Cage System
Expanding Innovations, Inc.
MAX
Jan 13, 2023K223474PathLoc-TA Expandable Lumbar Cage System
L&K BIOMED Co., Ltd., KR
MAX
Jan 6, 2023K223412LumiVy™ Lumbar IBF System
Vy Spine, LLC
MAX
Jan 5, 2023K223671CONDUIT LLIF Straight Inserters
Enztec Limited, NZ
MAX
Dec 28, 2022K223654Medussa-PL Cage
Medyssey USA, Inc.
MAX
Dec 19, 2022K2136534CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
Solco Biomedical Company India Private Limited, IN
MAX
Dec 16, 2022K223251Hexanium PLIF
Spinevision, S.A.S., FR
MAX
Dec 16, 2022K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek USA, Inc.
MAX
Dec 8, 2022K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)
Southern Medical (Pty) , Ltd., ZA
MAX
Dec 5, 2022K221806TruLift Lateral Expandable Spacer System & Lateral Plate System
Life Spine, Inc.
MAX
Nov 18, 2022K222455Calibrate LTX Interbody System
Alphatec Spine, Inc.
MAX
Nov 7, 2022K222732WaveForm A Interbody System
SeaSpine Orthopedics Corporation
MAX
Nov 3, 2022K221719ABTross ALIF Expandable Cage System
Aegis Spine, Inc.
MAX
Oct 26, 2022K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
Adcura, Inc.
MAX
Oct 18, 2022K222203DualXSLIM(R) T/PLIF
Amplify Surgical, Inc.
MAX
Oct 14, 2022K222797X-Pac Expandable Lumbar Cage System
Expanding Innovations, Inc.
MAX
Oct 14, 2022K221858ZSFab Lumbar Interbody System
Zsfab, Inc.
MAX
Oct 14, 2022K221172FOCUS Interbody System
Oc Medical Devices
MAX
Oct 7, 2022K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™
Alphatec Spine
MAX
Sep 29, 2022K213417Ghost Spacer System
Life Spine, Inc.
MAX
Sep 15, 2022K213641MONDRIAN ALIF Cage with Supplementary Fixation Plate
Ctl Medical Corporation
MAX
Sep 13, 2022K220953ChoiceSpine TigerShark™ M, Modular Interbody System
Choice Spine, LLC
MAX
Aug 25, 2022K221325CONDUIT Lateral Switch Plate
Medos International SARL, CH
MAX
Aug 17, 2022K221844TDM Lumbar Interbody Fusion Cage System
Tdm Co., Ltd., KR
MAX
Aug 12, 2022K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices
Carlsmed, Inc.
MAX
Jul 27, 2022K221687Pegasus-X Expandable PLIF System
GS Medical Co., Ltd., KR
MAX
Jul 22, 2022K221535Align Lumbar Interbody Fusion System
Acuity Surgical Devices, LLC
MAX
Jun 28, 2022K220449DePuy CONDUIT LLIF SQUID Inserter
Enztec Limited, NZ
MAX
Jun 21, 2022K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System
Nu Vasive, Incorporated
MAX
Jun 17, 2022K220523restor3d TiDAL Lumbar Interbody Fusion Device
Restor3D
MAX
Jun 9, 2022K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™
Alphatec Spine, Inc.
MAX
Jun 2, 2022K220581Zavation eZspand Interbody System
Zavation Medical Products, LLC
MAX
May 27, 2022K220902Navagio Lumbar Cage
Kalitec Medical, LLC
MAX
May 10, 2022K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
SeaSpine Orthopedics Corporation
MAX
May 4, 2022K213420WaveForm L System, WaveForm TO System, WaveForm TA System
SeaSpine Orthopedics Corporation
MAX
Apr 28, 2022K212477EARP Interbody System
Nvision Biomedical Technologies, Inc.
MAX
Apr 12, 2022K214010Anteralign Spinal System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek USA
MAX
Apr 12, 2022K212811Ti3Z Lumbar Interbody System
Zavation Medical Products, LLC
MAX
Mar 25, 2022K213355Toro-L Interbody Fusion System
Integrity Implants, Inc.
MAX

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