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 Nu Vasive, Incorporated, Medtronic Sofamor Danek USA, Inc. and Life Spine, Inc..

896
Total
896
Cleared
130d
Avg days
2007
Since
896 devices
241–264 of 896
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
Cleared Apr 14, 2020
COMET Lumbar Interbody Fusion Cage
K191353
Baui Biotech Co., Ltd.
Orthopedic · 329d
Cleared Apr 02, 2020
SIRION Lateral Lumbar Interbody System
K192006
Astura Medical, LLC
Orthopedic · 248d
Cleared Apr 02, 2020
EVOS Lumbar Interbody System
K200552
Cutting Edge Spine, LLC
Orthopedic · 30d
Cleared Mar 30, 2020
NuVasive Cohere Thoracolumbar Interbody System
K193541
Nu Vasive, Incorporated
Orthopedic · 101d
Cleared Mar 23, 2020
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K191788
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 264d
Cleared Mar 13, 2020
SeaSpine Skipjack System
K193418
SeaSpine Orthopedics Corporation
Orthopedic · 95d
Cleared Mar 09, 2020
MectaLIF Anterior Simple
K200048
Medacta International S.A.
Orthopedic · 60d
Cleared Mar 02, 2020
CarboClear Lumbar Cage System
K193378
CarboFix Orthopedics , Ltd.
Orthopedic · 88d
Cleared Feb 21, 2020
Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage
K190363
Omnia Medical, LLC
Orthopedic · 371d
Cleared Feb 20, 2020
Largo PEEK Interbody System
K193255
Flospine, LLC
Orthopedic · 86d
Cleared Feb 18, 2020
MOJAVE Expandable Interbody System
K193203
K2m, Inc.
Orthopedic · 90d
Cleared Feb 06, 2020
Steerable Plateau Ti
K193521
Life Spine, Inc.
Orthopedic · 49d
Cleared Jan 31, 2020
ProLift Expandable System
K193258
Life Spine, Inc.
Orthopedic · 66d
Cleared Jan 22, 2020
Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus
K192502
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 132d
Cleared Jan 21, 2020
Nexxt Matrixx System
K193370
Nexxt Spine, LLC
Orthopedic · 47d
Cleared Jan 14, 2020
SABLE Expandable Spacer
K192115
Globus Medical, Inc.
Orthopedic · 161d
Cleared Jan 13, 2020
nva, nvp, and nvt
K193645
Nvision Biomedical Technologies, Inc.
Orthopedic · 14d
Cleared Jan 09, 2020
TrellOss™-L MPF
K192687
Nexxt Spine, LLC
Orthopedic · 105d
Cleared Jan 06, 2020
EVOL ha - D Lateral Interbody Fusion System
K192497
Cutting Edge Spine, LLC
Orthopedic · 117d
Cleared Dec 20, 2019
Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
K192718
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Orthopedic · 84d