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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
Feb 19, 2021K202380Born PT-LIF Cage HA
Spineworxx AG, CH
MAX
Feb 12, 2021K200551MectaLIF Transforaminal TiPEEK
Medacta Inernational SA, CH
MAX
Feb 2, 2021K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers
Globus Medical, Inc.
MAX
Jan 29, 2021K203531XYPAN Expandable Lumbar Cage System
Aegis Spine, Inc.
MAX
Jan 25, 2021K203327VERTACONNECT TLIF Cage
Signus Medizintechnik, DE
MAX
Jan 15, 2021K203683CarboClear Lumbar Cage System
Carbofix Orthpedics , Ltd., IL
MAX
Jan 15, 2021K203308Ali Interbody Fusion System
Raed M. Ali, M.D., Inc.
MAX
Jan 12, 2021K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlor
Nu Vasive, Incorporated
MAX
Jan 6, 2021K202495SIRION Lateral Lumbar Interbody Fusion
Astura Medical, LLC
MAX
Dec 22, 2020K202820Australis Anterior Lumbar Cage System
Prism Surgical Designs Pty, Ltd., AU
MAX
Dec 22, 2020K202298Lucent XP, Lucent XP Curved
Spinal Elements, Inc.
MAX
Dec 22, 2020K201287Impulse Interbody Fusion System
Degen Medical
MAX
Dec 15, 2020K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System
SeaSpine Orthopedics Corporation
MAX
Dec 3, 2020K202034aprevo Intervertebral Body Fusion Device
Carlsmed, Inc.
MAX
Nov 25, 2020K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e
SeaSpine Orthopedics Corporation
MAX
Nov 6, 2020K202587ATEC Lateral Interbody System
Alphatec Spine, Inc.
MAX
Nov 3, 2020K202198FlareHawk Interbody Fusion System
Integrity Implants, Inc.
MAX
Oct 30, 2020K200316UNiD IB3D ALIF
Medicrea International SA, FR
MAX
Oct 29, 2020K201692NuVasive Modulus XLIF Interbody System
Nu Vasive, Incorporated
MAX
Oct 19, 2020K200084Zavation IBF System
Zavation Medical Products, LLC
MAX
Oct 13, 2020K202305Zavation IBF System
Zavation Medical Products, LLC
MAX
Oct 8, 2020K201939GAIA Lumbar Interbody Fusion Device (LIFD) Family
Printerprezz
MAX
Oct 7, 2020K201453Fortilink Cages with TiPlus Technology
Paradigm Spine GmbH
MAX
Oct 6, 2020K200953NuVasive® Cohere® Thoracolumbar Interbody System
Nu Vasive, Incorporated
MAX
Sep 25, 2020K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalo
Nu Vasive, Incorporated
MAX
Sep 23, 2020K201367FlareHawk TiHawk9 Interbody Fusion System
Integrity Implants, Inc.
MAX
Sep 10, 2020K201145X-Pac Expandable Lumbar Cage System
Expanding Innovations, Inc.
MAX
Sep 4, 2020K201721TruLift Expandable Spacer System
Life Spine, Inc.
MAX
Aug 28, 2020K200958MODULIF-A Anterior Lumbar Interbody Fusion System
Spinal Stability, LLC
MAX
Aug 26, 2020K201267Adaptix Interbody System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek
MAX
Aug 26, 2020K192863MONDRIAN Lumbar Interbody Fusion Cage System
Ctl Medical Corporation
MAX
Aug 4, 2020K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer
Life Spine, Inc.
MAX
Jul 15, 2020K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
Innovasis, Inc.
MAX
Jul 15, 2020K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Tita
Eit Emerging Implant Technologies GmbH, DE
MAX
Jul 2, 2020K193172Luna XD Ti Interbody Fusion System
Benvenue Medical, Inc.
MAX
Jun 19, 2020K193106SpineFrontier Lumbar Interbody Fusion Device System
Spinefrontier, Inc.
MAX
Jun 18, 2020K200283Medussa-PL Cage
Medyssey USA, Inc.
MAX
Jun 10, 2020K200879SeaSpine Meridian System, SeaSpine Regatta Lateral System
SeaSpine Orthopedics Corporation
MAX
May 29, 2020K200920Idys ALIF ZP 3DTi
Clariance, Sas, FR
MAX
May 21, 2020K200969NEXXT MATRIXX System
Nexxt Spine, LLC
MAX
May 18, 2020K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, C
MiRus, LLC
MAX
May 13, 2020K200991EVOL Spinal Interbody System
Cutting Edge Spine, LLC
MAX
May 12, 2020K193457AUDERE Lumbar Spacer System
Met One Technologies
MAX
Apr 30, 2020K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
Spineex, Inc.
MAX
Apr 24, 2020K193636SeaSpine Reef TH System
SeaSpine Orthopedics Corporation
MAX
Apr 15, 2020K200613Tritanium® X TL Expandable Curved Posterior Lumbar Cage
Stryker Corporation
MAX
Apr 14, 2020K191353COMET Lumbar Interbody Fusion Cage
Baui Biotech Co., Ltd., TW
MAX
Apr 2, 2020K200552EVOS Lumbar Interbody System
Cutting Edge Spine, LLC
MAX
Apr 2, 2020K192006SIRION Lateral Lumbar Interbody System
Astura Medical, LLC
MAX
Mar 30, 2020K193541NuVasive Cohere Thoracolumbar Interbody System
Nu Vasive, Incorporated
MAX

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