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
793–816 of 897
Cleared Aug 12, 2010
AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX
K101051
Stryker Spine
Orthopedic · 119d
Cleared Aug 11, 2010
AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
K100865
Stryker Spine
Orthopedic · 135d
Cleared Aug 10, 2010
ATLAS SPINE PIVOTING SYSTEM
K100743
Atlas Spine, Inc.
Orthopedic · 147d
Cleared Jul 16, 2010
JULIET OL
K101720
Spineart
Orthopedic · 28d
Cleared Jun 30, 2010
S-LIF INTERVERTEBRAL BODY FUSION DEVICE
K092815
Spinefrontier, Inc.
Orthopedic · 289d
Cleared Jun 02, 2010
CLYDESDALE SPINAL SYSTEM
K100175
Medtronic Sofamor Danek
Orthopedic · 132d
Cleared May 13, 2010
SYNTHES T-PAL SPACER
K100089
Synthes Spine
Orthopedic · 121d
Cleared Apr 26, 2010
CRESCENT SPINAL SYSTEM
K094025
Medtronic Sofamor Danek
Orthopedic · 117d
Cleared Mar 11, 2010
AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX
K093864
Stryker Corp.
Orthopedic · 84d
Cleared Feb 04, 2010
ESL SPINAL SYSTEM
K092574
Ebi, L.P.
Orthopedic · 167d
Cleared Jan 28, 2010
VALEO SPACER SYSTEM
K091278
Amedica Corp.
Orthopedic · 272d
Cleared Jan 06, 2010
4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
K092162
Solco Biomedical Co., Ltd.
Orthopedic · 174d
Cleared Dec 23, 2009
PATRIOT TRANSCONTINENTAL LLIF SPACER
K093242
Globus Medical, Inc.
Orthopedic · 69d
Cleared Dec 23, 2009
AVS PL PEEK SPACERS
K093704
Stryker Corp.
Orthopedic · 22d
Cleared Sep 29, 2009
PERIMETER INTERBODY FUSION DEVICE
K090353
Medtronic Sofamor Danek
Orthopedic · 230d
Cleared Sep 25, 2009
SPINAL USA INTERBODY CAGES
K092193
Spinal USA
Orthopedic · 66d
Cleared Sep 14, 2009
DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
K091638
Spinefrontier, Inc.
Orthopedic · 102d
Cleared Aug 07, 2009
IBEX SPINAL SYSTEM
K091381
Ebi, L.P.
Orthopedic · 88d
Cleared Jun 25, 2009
MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM
K090507
Ldr Spine USA
Orthopedic · 120d
Cleared May 22, 2009
DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS
K081917
Depuy Spine, Inc.
Orthopedic · 323d
Cleared May 19, 2009
GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
K090425
Alphatec Spine, Inc.
Orthopedic · 89d
Cleared May 19, 2009
DEPUY SPINE LATERAL SYSTEM
K090899
Depuy Spine, Inc.
Orthopedic · 48d
Cleared Apr 24, 2009
STRYKER SPINE AVS PL PEEK SPACERS
K090816
Stryker Corp.
Orthopedic · 30d
Cleared Apr 22, 2009
AVS ANTERIOR LARGE PEEK SPACERS
K090166
Stryker Corp.
Orthopedic · 90d