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
721–744 of 897
Cleared Jun 29, 2012
LOOP CAGE
K121332
Advanced Medical Technologies AG
Orthopedic · 57d
Cleared Jun 29, 2012
WAVE D CAGE
K121333
Advanced Medical Technologies AG
Orthopedic · 57d
Cleared Jun 28, 2012
NUVASIVE COROENT TITANIUM SYSTEM
K120918
Nuvasive, Inc.
Orthopedic · 93d
Cleared Jun 15, 2012
TM-400 DEVICE
K120203
Zimmer Trabecular Metal Technology, Inc.
Orthopedic · 144d
Cleared Jun 15, 2012
MEDYSSY LT CAGE SYSTEM
K121246
Medyssey Co, Ltd.
Orthopedic · 51d
Cleared Jun 13, 2012
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K121129
Spineology, Inc.
Orthopedic · 61d
Cleared May 29, 2012
TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
K113561
Zimmer Trabecular Metal Technology
Orthopedic · 180d
Cleared May 23, 2012
LUCENT OR LUCENT MAGNUM
K110632
Spinal Elements, Inc.
Orthopedic · 446d
Cleared May 08, 2012
PLATEAU SPACER SYSTEM
K121116
Life Spine
Orthopedic · 26d
Cleared May 01, 2012
LATERAL FUSION DEVICE
K112986
Integra Spine (Integra Lifesciences)
Orthopedic · 208d
Cleared Apr 19, 2012
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120063
L & K Biomed Co., Ltd.
Orthopedic · 101d
Cleared Apr 18, 2012
TWIN PEAKS LUMBAR CAGE
K112696
Qualgenix, LLC
Orthopedic · 216d
Cleared Apr 09, 2012
CAPSTONE CONTROL SPINAL SYSTEM
K120368
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Mar 28, 2012
ZAVATION IBF SYSTEM
K120576
Zavation, LLC
Orthopedic · 30d
Cleared Mar 13, 2012
ASFORA BULLET CAGE
K112648
Medical Designs, LLC
Orthopedic · 183d
Cleared Mar 12, 2012
RELIANCE LUMBAR IBF SYSTEM
K113540
Reliance Medical Systems, LLC
Orthopedic · 103d
Cleared Mar 05, 2012
MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI
K111792
Signus Medizintechnik GmbH
Orthopedic · 252d
Cleared Mar 05, 2012
PLIF CAGE
K113478
Eisertech, LLC
Orthopedic · 103d
Cleared Feb 29, 2012
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
K120293
Spineology, Inc.
Orthopedic · 29d
Cleared Feb 28, 2012
MECTALIF TRANSFORAMINAL
K120024
Medacta International S.A.
Orthopedic · 56d
Cleared Feb 06, 2012
PATHWAY AVID
K111726
Custom Spine, Inc.
Orthopedic · 231d
Cleared Feb 06, 2012
PERIMETER INTERBODY FUSION DEVICE
K113642
Medtronic Sofamor Danek USA
Orthopedic · 56d
Cleared Jan 26, 2012
SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
K113030
Spineology, Inc.
Orthopedic · 106d
Cleared Jan 26, 2012
RISE SPACER
K113447
Globus Medical, Inc.
Orthopedic · 66d