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
409–432 of 896
Cleared May 19, 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 284d
Cleared May 10, 2017
MOJAVE Expandable Interbody System
K171097
K2m, Inc.
Orthopedic · 27d
Cleared May 01, 2017
NuVasive CoRoent Ti-C System
K163707
Nu Vasive, Incorporated
Orthopedic · 123d
Cleared Apr 06, 2017
Leva Anterior Expandable Spacer System
K163246
Spine Wave, Inc.
Orthopedic · 139d
Cleared Mar 16, 2017
NuVasive Modulus XLIF Interbody System
K163230
Nu Vasive, Incorporated
Orthopedic · 119d
Cleared Mar 08, 2017
Rampart(TM) T Lumbar Interbody Fusion Device
K163409
Spineology, Inc.
Orthopedic · 93d
Cleared Feb 22, 2017
SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer
K152022
Globus Medical, Inc.
Orthopedic · 582d
Cleared Jan 30, 2017
Elite Expandable Interbody Fusion Device
K162879
Spineology, Inc.
Orthopedic · 108d
Cleared Dec 22, 2016
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System
K162446
Orthofix, Inc.
Orthopedic · 112d
Cleared Dec 12, 2016
COUGAR® LS Lateral Cage System and COUGAR® System
K162327
Medos International SARL
Orthopedic · 115d
Cleared Nov 09, 2016
Tritanium® PL Cage
K162262
Stryker
Orthopedic · 90d
Cleared Nov 01, 2016
T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
K162358
Synthes USA Products, LLC
Orthopedic · 70d
Cleared Oct 28, 2016
SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene
K162715
SeaSpine Orthopedics Corporation
Orthopedic · 29d
Cleared Oct 18, 2016
Rampart D Lumbar Interbody Fusion Device
K160074
Spineology, Inc.
Orthopedic · 278d
Cleared Sep 21, 2016
Cascadia Interbody System
K162264
K2m, Inc.
Orthopedic · 41d
Cleared Sep 12, 2016
JULIET® LL Lateral Lumbar Cage
K161888
Spineart
Orthopedic · 63d
Cleared Aug 25, 2016
NuVasive Lumbar Interbody Implants
K161230
Nu Vasive, Incorporated
Orthopedic · 115d
Cleared Aug 24, 2016
XYcor® Expandable Spinal Spacer System
K160646
Alphatec Spine, Inc.
Orthopedic · 170d
Cleared Jul 21, 2016
Tritanium® PL Cage
K160955
Stryker
Orthopedic · 107d
Cleared Jul 15, 2016
Juliet® Ti
K153621
Spineart
Orthopedic · 210d
Cleared Jul 14, 2016
Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device
K160906
Spineology, Inc.
Orthopedic · 104d
Cleared Jul 11, 2016
MLX™ - Medial Lateral Expandable Lumbar Interbody System
K153105
Nu Vasive, Incorporated
Orthopedic · 258d
Cleared Jul 08, 2016
AccuLIF TL and PL Cage
K160715
Stryker Corporation
Orthopedic · 115d
Cleared Jun 28, 2016
CoRoent® Ti-C System
K160916
Nu Vasive, Incorporated
Orthopedic · 88d