MAX · Class II · 21 CFR 888.3080

FDA Product Code MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

FDA product code MAX covers lumbar intervertebral fusion devices with bone graft.

These spinal implants are designed to stabilize a vertebral segment and promote bone fusion across the disc space. They are used in both minimally invasive and open lumbar fusion procedures.

MAX devices are Class II medical devices, regulated under 21 CFR 888.3080 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Life Spine, Inc., Nu Vasive, Incorporated and SeaSpine Orthopedics Corporation.

891
Total
891
Cleared
129d
Avg days
2007
Since
891 devices
193–216 of 891
Cleared Mar 03, 2021
FORZA Ti Spacer System
K203576
Orthofix, Inc.
Orthopedic · 86d
Cleared Feb 19, 2021
Born PT-LIF Cage HA
K202380
Spineworxx AG
Orthopedic · 183d
Cleared Feb 19, 2021
Duo Expandable Interbody Fusion System
K210155
Spineology, Inc.
Orthopedic · 29d
Cleared Feb 12, 2021
MectaLIF Transforaminal TiPEEK
K200551
Medacta Inernational SA
Orthopedic · 346d
Cleared Feb 02, 2021
INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers
K203278
Globus Medical, Inc.
Orthopedic · 88d
Cleared Jan 29, 2021
XYPAN Expandable Lumbar Cage System
K203531
Aegis Spine, Inc.
Orthopedic · 58d
Cleared Jan 25, 2021
VERTACONNECT TLIF Cage
K203327
Signus Medizintechnik
Orthopedic · 74d
Cleared Jan 15, 2021
Ali Interbody Fusion System
K203308
Raed M. Ali, M.D., Inc.
Orthopedic · 66d
Cleared Jan 15, 2021
CarboClear Lumbar Cage System
K203683
Carbofix Orthpedics , Ltd.
Orthopedic · 29d
Cleared Jan 12, 2021
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System
K203201
Nu Vasive, Incorporated
Orthopedic · 75d
Cleared Jan 06, 2021
SIRION Lateral Lumbar Interbody Fusion
K202495
Astura Medical, LLC
Orthopedic · 128d
Cleared Dec 22, 2020
Impulse Interbody Fusion System
K201287
Degen Medical
Orthopedic · 222d
Cleared Dec 22, 2020
Lucent XP, Lucent XP Curved
K202298
Spinal Elements, Inc.
Orthopedic · 131d
Cleared Dec 22, 2020
Australis Anterior Lumbar Cage System
K202820
Prism Surgical Designs Pty, Ltd.
Orthopedic · 89d
Cleared Dec 15, 2020
WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System
K201755
SeaSpine Orthopedics Corporation
Orthopedic · 169d
Cleared Dec 03, 2020
aprevo Intervertebral Body Fusion Device
K202034
Carlsmed, Inc.
Orthopedic · 133d
Cleared Nov 25, 2020
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene
K201193
SeaSpine Orthopedics Corporation
Orthopedic · 205d
Cleared Nov 06, 2020
ATEC Lateral Interbody System
K202587
Alphatec Spine, Inc.
Orthopedic · 59d
Cleared Nov 03, 2020
FlareHawk Interbody Fusion System
K202198
Integrity Implants, Inc.
Orthopedic · 90d
Cleared Oct 30, 2020
UNiD IB3D ALIF
K200316
Medicrea International SA
Orthopedic · 266d
Cleared Oct 29, 2020
NuVasive Modulus XLIF Interbody System
K201692
Nu Vasive, Incorporated
Orthopedic · 129d
Cleared Oct 19, 2020
Zavation IBF System
K200084
Zavation Medical Products, LLC
Orthopedic · 278d
Cleared Oct 13, 2020
Zavation IBF System
K202305
Zavation Medical Products, LLC
Orthopedic · 60d
Cleared Oct 08, 2020
GAIA Lumbar Interbody Fusion Device (LIFD) Family
K201939
Printerprezz
Orthopedic · 87d