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
433–456 of 896
Cleared Jun 09, 2016
Lucent Intervertebral Body Fusion Device
K152011
Spinal Elements, Inc.
Orthopedic · 324d
Cleared Apr 15, 2016
Leva Spacer System
K153222
Spine Wave, Inc.
Orthopedic · 161d
Cleared Apr 13, 2016
SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer
K143578
Globus Medical, Inc.
Orthopedic · 483d
Cleared Apr 13, 2016
NuVasive CoRoent Thoracolumbar System
K153419
Nu Vasive, Incorporated
Orthopedic · 140d
Cleared Mar 24, 2016
NuVasive® Lumbar Interbody Implants
K153782
Nu Vasive, Incorporated
Orthopedic · 84d
Cleared Mar 17, 2016
NuVasive® TLX Interbody System
K153627
Nu Vasive, Incorporated
Orthopedic · 90d
Cleared Mar 16, 2016
SUSTAIN Additional Implants
K151665
Globus Medical, Inc.
Orthopedic · 271d
Cleared Mar 07, 2016
ProLift Expandable System
K153400
Life Spine, Inc.
Orthopedic · 104d
Cleared Mar 07, 2016
PERIMETER Interbody Fusion Device
K160418
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared Feb 04, 2016
Rampart A Lumbar Interbody Fusion Device
K153082
Spineology, Inc.
Orthopedic · 104d
Cleared Jan 20, 2016
AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer
K151726
Stryker Corporation
Orthopedic · 208d
Cleared Jan 15, 2016
Spine Wave Gen II Expandable Interbody System
K152620
Spine Wave, Inc.
Orthopedic · 123d
Cleared Jan 14, 2016
FORZA PTC Spacer System
K152475
Orthofix, Inc.
Orthopedic · 136d
Cleared Dec 15, 2015
AccuLIF TL and PL Cage
K152651
Stryker Corporation
Orthopedic · 90d
Cleared Nov 20, 2015
CONCORDE Bullet Lumbar Interbody System
K151773
Medos International SARL
Orthopedic · 143d
Cleared Nov 19, 2015
Tritanium PL Cage
K152304
Stryker
Orthopedic · 97d
Cleared Nov 13, 2015
PIVOX(tm) Oblique Lateral Spinal System
K152277
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 93d
Cleared Oct 08, 2015
CONCORDE Bullet Spinal System
K151352
Medos International SARL
Orthopedic · 141d
Cleared Sep 10, 2015
NuVasive CoRoent Lumbar System
K151472
Nu Vasive, Incorporated
Orthopedic · 101d
Cleared Aug 20, 2015
Cascadia Interbody System
K150481
K2m, Inc.
Orthopedic · 177d
Cleared Aug 18, 2015
LnK Lumbar Interbody Fusion Cage System
K151140
L & K Biomed Co., Ltd.
Orthopedic · 111d
Cleared Aug 06, 2015
CAPSTONE Spinal System, CLYDESDALE Spinal System
K151128
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 100d
Cleared Aug 06, 2015
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System
K151374
Nu Vasive, Incorporated
Orthopedic · 76d
Cleared Jul 22, 2015
Rampart-T Interbody Fusion System
K151020
Spineology, Inc.
Orthopedic · 97d