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
625–648 of 897
Cleared Apr 03, 2014
ALEUTIAN IBF SYSTEM
K133614
K2m, Inc.
Orthopedic · 129d
Cleared Mar 31, 2014
INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60
K133721
Pinnacle Spine Group, LLC
Orthopedic · 116d
Cleared Mar 27, 2014
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
K133455
Pioneer Surgical Technology, Inc.
Orthopedic · 135d
Cleared Mar 20, 2014
CAMBER SPINE DIAGON OBLIQUE CAGE
K134038
Camber Spine
Orthopedic · 79d
Cleared Mar 14, 2014
STERISPINE LC CAGE
K133893
Safe Orthopaedics
Orthopedic · 84d
Cleared Mar 13, 2014
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133205
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 146d
Cleared Mar 06, 2014
ELITE IBF
K133459
Innova Spinal Technologies, LLC
Orthopedic · 114d
Cleared Feb 10, 2014
OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070
K133583
Interventional Spine, Inc.
Orthopedic · 81d
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 31, 2014
INTERBODY CAGE SYSTEM
K133967
Aurora Spine
Orthopedic · 38d
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 22, 2014
AESCULAP PEEK XP SPINAL IMPLANT SYSTEM
K132421
Aesculap Implant Systems, Inc.
Orthopedic · 170d
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 13, 2013
GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM
K130913
Genesys Spine
Orthopedic · 255d
Cleared Dec 11, 2013
CLYDESDALE SPINAL SYSTEM
K132897
Medtronic Sofamor Danek, Inc.
Orthopedic · 86d
Cleared Dec 09, 2013
K7 LUMBAR SPACERS
K133126
K7, LLC
Orthopedic · 70d
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