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
481–504 of 896
Cleared Jul 01, 2014
ALTERA SPACER
K140411
Globus Medical, Inc.
Orthopedic · 133d
Cleared Jun 26, 2014
COROENT THORACOLUMBAR IMPLANTS
K140659
Nu Vasive, Incorporated
Orthopedic · 104d
Cleared Jun 13, 2014
BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL
K140759
Medos International SARL
Orthopedic · 79d
Cleared May 27, 2014
SKYHAWK INTERBODY FUSION SYSTEM
K140709
Orthofix, Inc.
Orthopedic · 67d
Cleared Apr 25, 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607
Exactech, Inc.
Orthopedic · 520d
Cleared Apr 18, 2014
JULIET OL
K140474
Spineart
Orthopedic · 52d
Cleared Apr 07, 2014
ABACUS TM SPACER SYSTEM
K140007
Spine Wave, Inc.
Orthopedic · 95d
Cleared Apr 03, 2014
ALEUTIAN IBF SYSTEM
K133614
K2m, Inc.
Orthopedic · 129d
Cleared Mar 13, 2014
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133205
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 146d
Cleared Feb 03, 2014
DEROYAL SPINE SPACER SYSTEM
K131292
Deroyal Industries, Inc.
Orthopedic · 273d
Cleared Feb 03, 2014
JULIET LL LATERAL LUMBAR CAGE
K133557
Spineart
Orthopedic · 76d
Cleared Jan 30, 2014
ARDIS INTERBODY SYSTEM
K133184
Zimmer Spine, Inc.
Orthopedic · 105d
Cleared Jan 30, 2014
MECTALIF TIPEEK
K133192
Medacta International
Orthopedic · 105d
Cleared Jan 09, 2014
RAMPART-L
K133371
Spineology, Inc.
Orthopedic · 69d
Cleared Jan 03, 2014
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM
K133645
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 37d
Cleared Dec 24, 2013
COROENT STERILE IMPLANTS SYSTEM
K132601
Nu Vasive, Incorporated
Orthopedic · 126d
Cleared Dec 20, 2013
INFIX ANTERIOR LUMBAR SYSTEM
K132790
Zimmer Spine, Inc.
Orthopedic · 105d
Cleared Dec 20, 2013
CAPSTONE SPINAL SYSTEM
K133650
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 23d
Cleared Dec 11, 2013
CLYDESDALE SPINAL SYSTEM
K132897
Medtronic Sofamor Danek, Inc.
Orthopedic · 86d
Cleared Nov 22, 2013
CRESCENT SPINAL SYSTEM
K133216
Medtronic Sofamor Danek, Inc.
Orthopedic · 35d
Cleared Nov 01, 2013
PERIMETER INTERBODY FUSION DEVICE
K131669
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 147d
Cleared Oct 04, 2013
STAXX IBL SYSTEM
K132719
Spine Wave, Inc.
Orthopedic · 35d
Cleared Sep 26, 2013
PERIMETER INTERBODY FUSION DEVICE
K132700
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 16, 2013
RAMPART-O, RAMPART-T
K132053
Spineology, Inc.
Orthopedic · 75d