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
265–288 of 891
Cleared Dec 03, 2019
SeaSpine Beachside System
K192132
SeaSpine Orthopedics Corporation
Orthopedic · 118d
Cleared Nov 26, 2019
Peridot Intervertebral body fusion System
K192026
Gbs Commonwealth Co., Ltd.
Orthopedic · 120d
Cleared Nov 25, 2019
Cortina™ [MAX] Lumbar Cage System
K192248
Neurostructures, Inc.
Orthopedic · 98d
Cleared Nov 14, 2019
LongBow Ti
K190721
Life Spine, Inc.
Orthopedic · 239d
Cleared Nov 01, 2019
XIHPOS™ ZFUZE™ Interbody Fusion System
K190544
Difusion Technologies
Orthopedic · 242d
Cleared Oct 30, 2019
IB3D ALIF
K191134
Medicrea International SA
Orthopedic · 184d
Cleared Oct 28, 2019
3d Cage
K180347
Fims Co., Ltd.
Orthopedic · 627d
Cleared Oct 18, 2019
NuVasive Modulus XLIF Interbody System
K192760
Nu Vasive, Incorporated
Orthopedic · 18d
Cleared Oct 15, 2019
DualX Lumbar Intervertebral Body Fusion Device
K192434
Amplify Surgical, Inc.
Orthopedic · 40d
Cleared Sep 25, 2019
TranS1 Interbody Fusion System
K191791
Trans1
Orthopedic · 84d
Cleared Sep 23, 2019
SPIRA Open Matrix ALIF and LLIF
K190483
Camber Spine Technologies
Orthopedic · 208d
Cleared Sep 18, 2019
4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
K190563
Solco Biomedical Co., Ltd.
Orthopedic · 197d
Cleared Sep 18, 2019
HEDRON Lumbar Spacers
K191391
Globus Medical, Inc.
Orthopedic · 117d
Cleared Sep 16, 2019
AccelFix Lumbar Interbody Fusion Cage System
K190708
L & K Biomed Co., Ltd.
Orthopedic · 181d
Cleared Sep 12, 2019
Republic Spine Restore Intervertebral Body Fusion System
K190398
Republic Spine, LLC
Orthopedic · 205d
Cleared Sep 12, 2019
Ali Interbody Fusion System
K191516
Raed M. Ali, M.D., Inc.
Orthopedic · 97d
Cleared Aug 30, 2019
Triton Cage
K183407
Medyssey USA, Inc.
Orthopedic · 263d
Cleared Aug 19, 2019
Zavation eZspand Interbody System
K191339
Zavation Medical Products, LLC
Orthopedic · 91d
Cleared Aug 12, 2019
ATEC Lateral Interbody System
K191311
Alphatec Spine, Inc.
Orthopedic · 89d
Cleared Jul 25, 2019
Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage
K183249
Stryker Spine
Orthopedic · 246d
Cleared Jul 23, 2019
ProLift Expandable System
K190488
Life Spine, Inc.
Orthopedic · 145d
Cleared Jul 18, 2019
FAVO S-TLIF
K190680
Silony Medical GmbH
Orthopedic · 122d
Cleared Jul 15, 2019
UNiD Patient-matched PLIF cage
K182158
Medicrea International SA
Orthopedic · 340d
Cleared Jul 10, 2019
Velofix TLIF Cage
K183243
U&I Corporation
Orthopedic · 231d