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
217–240 of 891
Cleared Oct 07, 2020
Fortilink Cages with TiPlus Technology
K201453
Paradigm Spine GmbH
Orthopedic · 128d
Cleared Oct 06, 2020
NuVasive® Cohere® Thoracolumbar Interbody System
K200953
Nu Vasive, Incorporated
Orthopedic · 180d
Cleared Sep 25, 2020
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic 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, 3DP Interfixated ALIF System
K201820
Nu Vasive, Incorporated
Orthopedic · 86d
Cleared Sep 23, 2020
FlareHawk TiHawk9 Interbody Fusion System
K201367
Integrity Implants, Inc.
Orthopedic · 124d
Cleared Sep 10, 2020
X-Pac Expandable Lumbar Cage System
K201145
Expanding Innovations, Inc.
Orthopedic · 134d
Cleared Sep 04, 2020
TruLift Expandable Spacer System
K201721
Life Spine, Inc.
Orthopedic · 73d
Cleared Aug 28, 2020
MODULIF-A Anterior Lumbar Interbody Fusion System
K200958
Spinal Stability, LLC
Orthopedic · 140d
Cleared Aug 26, 2020
MONDRIAN Lumbar Interbody Fusion Cage System
K192863
Ctl Medical Corporation
Orthopedic · 324d
Cleared Aug 26, 2020
Adaptix Interbody System with Titan nanoLOCK Surface Technology
K201267
Medtronic Sofamor Danek
Orthopedic · 106d
Cleared Aug 04, 2020
Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer
K201500
Life Spine, Inc.
Orthopedic · 60d
Cleared Jul 15, 2020
EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage
K201605
Eit Emerging Implant Technologies GmbH
Orthopedic · 30d
Cleared Jul 15, 2020
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
K201614
Innovasis, Inc.
Orthopedic · 30d
Cleared Jul 02, 2020
Luna XD Ti Interbody Fusion System
K193172
Benvenue Medical, Inc.
Orthopedic · 230d
Cleared Jun 19, 2020
SpineFrontier Lumbar Interbody Fusion Device System
K193106
Spinefrontier, Inc.
Orthopedic · 224d
Cleared Jun 18, 2020
Medussa-PL Cage
K200283
Medyssey USA, Inc.
Orthopedic · 135d
Cleared Jun 10, 2020
SeaSpine Meridian System, SeaSpine Regatta Lateral System
K200879
SeaSpine Orthopedics Corporation
Orthopedic · 69d
Cleared May 29, 2020
Idys ALIF ZP 3DTi
K200920
Clariance, Sas
Orthopedic · 53d
Cleared May 21, 2020
NEXXT MATRIXX System
K200969
Nexxt Spine, LLC
Orthopedic · 38d
Cleared May 18, 2020
MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
K191906
MiRus, LLC
Orthopedic · 307d
Cleared May 13, 2020
EVOL Spinal Interbody System
K200991
Cutting Edge Spine, LLC
Orthopedic · 28d
Cleared May 12, 2020
AUDERE Lumbar Spacer System
K193457
Met One Technologies
Orthopedic · 148d
Cleared Apr 30, 2020
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
K200816
Spineex, Inc.
Orthopedic · 31d
Cleared Apr 24, 2020
SeaSpine Reef TH System
K193636
SeaSpine Orthopedics Corporation
Orthopedic · 119d
Cleared Apr 15, 2020
Tritanium® X TL Expandable Curved Posterior Lumbar Cage
K200613
Stryker Corporation
Orthopedic · 37d