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..

897
Total
897
Cleared
130d
Avg days
2007
Since
897 devices
505–528 of 897
Cleared May 06, 2016
NeoFuse HA Enhanced PLIF/TLIF
K153615
Ht Medical, LLC
Orthopedic · 141d
Cleared May 04, 2016
SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
K153783
Spinevision S.A.
Orthopedic · 125d
Cleared Apr 26, 2016
Genesys Spine Apache Interbody Fusion System
K153123
Genesys Spine
Orthopedic · 180d
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 Apr 04, 2016
Opticage(R) Expandable Interbody Fusion Device
K160464
Interventional Spine, Inc.
Orthopedic · 45d
Cleared Mar 31, 2016
Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
K153495
Ldr Spine USA
Orthopedic · 115d
Cleared Mar 25, 2016
SurgTech Interbody System
K152200
Surgtech, Inc.
Orthopedic · 232d
Cleared Mar 24, 2016
NuVasive® Lumbar Interbody Implants
K153782
Nu Vasive, Incorporated
Orthopedic · 84d
Cleared Mar 24, 2016
Cascadia Interbody System
K160547
K2m
Orthopedic · 27d
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 25, 2016
Cogent Lateral Interbody System
K151406
Cogent Spine, LLC
Orthopedic · 275d
Cleared Feb 24, 2016
SpineView X-Pac Expandable Lumbar Cage System
K152539
Spine View, Inc.
Orthopedic · 173d
Cleared Feb 04, 2016
Rampart A Lumbar Interbody Fusion Device
K153082
Spineology, Inc.
Orthopedic · 104d
Cleared Jan 28, 2016
Half Dome Posterior Lumbar Interbody System
K152512
Astura Medical
Orthopedic · 148d
Cleared Jan 21, 2016
Biomet Spine Fusion System
K153695
Biomet Spine, LLC
Orthopedic · 29d
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 Jan 14, 2016
Spine Innovation Interbody System
K153356
Spine Innovation, LLC
Orthopedic · 55d