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
745–768 of 897
Cleared Jan 20, 2012
OPTICAGE INTERBODY FUSION DEVICE
K113527
Interventional Spine, Inc.
Orthopedic · 51d
Cleared Jan 10, 2012
ALEUTIAN SYSTEM
K113138
K2m, Inc.
Orthopedic · 77d
Cleared Dec 20, 2011
CLYDESDALE(R) SPINAL SYSTEM
K113528
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared Dec 14, 2011
4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
K112316
4-Web, Inc.
Orthopedic · 125d
Cleared Dec 13, 2011
COUGAR SYSTEM
K113348
Johnson & Johnson
Orthopedic · 29d
Cleared Dec 12, 2011
ACCULIF TL CAGE
K113465
Coalign Innovations, Inc.
Orthopedic · 20d
Cleared Dec 01, 2011
ACCULIF TL-PEEK IBF CAGE
K112095
Coalign Innovations, Inc.
Orthopedic · 132d
Cleared Nov 21, 2011
CLYDESDALES SPINAL SYSTEM
K112405
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 91d
Cleared Nov 09, 2011
TELAMON PEEK SPINAL SYSTEM
K110562
Medtronic Sofamor Danek USA
Orthopedic · 254d
Cleared Nov 08, 2011
PROW FUSION
K112359
Nlt Spine, Ltd.
Orthopedic · 84d
Cleared Oct 26, 2011
BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
K111512
Thompson Mis, Inc.
Orthopedic · 147d
Cleared Oct 25, 2011
VUSION(R) OS
K111965
Ortho Development
Orthopedic · 106d
Cleared Oct 24, 2011
VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
K110783
L & K Biomed Co., Ltd.
Orthopedic · 217d
Cleared Oct 17, 2011
GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
K111354
GS Medical Co., Ltd.
Orthopedic · 157d
Cleared Oct 17, 2011
ZYSTON STRAIGHT SPACER SYSTEM
K112014
Biomet Spine
Orthopedic · 95d
Cleared Oct 11, 2011
CONCORDE BULLET SPINAL SYSTEM
K110694
Johnson & Johnson
Orthopedic · 211d
Cleared Sep 28, 2011
SPINEFRONTIER LUMBAR IBF SYSTEM
K111553
Spinefrontier, Inc.
Orthopedic · 117d
Cleared Sep 28, 2011
PIONEER CROSSFUSE II IBF/VBR SYSTEM
K112496
Pioneer Surgical Technology, Inc.
Orthopedic · 30d
Cleared Sep 26, 2011
SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
K111880
Spineology, Inc.
Orthopedic · 87d
Cleared Sep 13, 2011
MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
K110659
Medical Concepts, Inc.
Orthopedic · 190d
Cleared Sep 08, 2011
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
K111166
Spineworks, LLC
Orthopedic · 135d
Cleared Aug 24, 2011
PERIMETER INTERBODY FUSION DEVICE
K111525
Medtronic Sofamor Danek
Orthopedic · 84d
Cleared Aug 09, 2011
CRESCENT (R) SPINAL SYSTEM TITANIUM
K110543
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Jul 20, 2011
PATHWAY MODEL 07XXXX
K111774
Custom Spine
Orthopedic · 27d