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
673–696 of 897
Cleared Jun 04, 2013
INFILL OBLIQUE TLIF DEVICE
K124012
Pinnacle Spine Group, LLC
Orthopedic · 159d
Cleared May 30, 2013
ALEUTIAN SPINAL SYSTEM
K130699
K2m, Inc.
Orthopedic · 77d
Cleared May 30, 2013
RAMPART O
K131216
Spineology, Inc.
Orthopedic · 30d
Cleared May 24, 2013
SYNTHES SYNCAGE EVOLUTION SPACER
K122639
Synthes USA Products, LLC
Orthopedic · 268d
Cleared May 13, 2013
LATIS SPACER
K123913
Globus Medical, Inc.
Orthopedic · 145d
Cleared May 13, 2013
IMSE P-TLIF
K130506
Institute of Musculoskeletal Science & Education
Orthopedic · 75d
Cleared May 01, 2013
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC
K130434
Exactech, Inc.
Orthopedic · 69d
Cleared Apr 26, 2013
PANTHEON SPINAL IBFD SYSTEM
K113781
Pantheon Spinal
Orthopedic · 491d
Cleared Apr 18, 2013
EPICAGE INTERBODY FUSION DEVICE
K130548
Alphatec Spine, Inc.
Orthopedic · 45d
Cleared Apr 11, 2013
STAXX(R) IB SYSTEM
K123461
Spine Wave, Inc.
Orthopedic · 153d
Cleared Apr 09, 2013
CAPSTONE L SPINAL SYSTEM
K123978
Medtronic Sofamor Danek USA
Orthopedic · 104d
Cleared Apr 03, 2013
ACCULIF XL CAGE
K130194
Coalign Innovations, Inc.
Orthopedic · 65d
Cleared Apr 01, 2013
TRANS1LATERAL INTERBODY FUSION SYSTEM
K123997
Trans1, Inc.
Orthopedic · 96d
Cleared Mar 28, 2013
INTESS LUMBAR CAGE
K123100
Kalitec Direct, LLC
Orthopedic · 177d
Cleared Mar 25, 2013
RAMPART O AND RAMPART P
K130396
Spineology, Inc.
Orthopedic · 34d
Cleared Mar 22, 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST
K122037
Medtronic Sofamor Danek, Inc.
Orthopedic · 254d
Cleared Mar 22, 2013
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K123652
Spineology, Inc.
Orthopedic · 115d
Cleared Mar 01, 2013
TM ARDIS INTERBODY SYSTEM INSERTER
K123602
Zimmer Trabecular Metal Technology
Orthopedic · 100d
Cleared Feb 21, 2013
LUCENT
K122967
Spinal Elements, Inc.
Orthopedic · 149d
Cleared Feb 07, 2013
XIPHOS
K123969
Difusion Technologies
Orthopedic · 43d
Cleared Jan 23, 2013
ACCULIF TL-PEEK CAGE
K123281
Coalign Innovations, Inc.
Orthopedic · 93d
Cleared Jan 18, 2013
INNESIS PEEK CAGE
K120464
Bk Meditech, Co., Ltd.
Orthopedic · 338d
Cleared Jan 18, 2013
CALIBER SPACERS
K123231
Globus Medical, Inc.
Orthopedic · 94d
Cleared Jan 14, 2013
ACCULIF TL AND PL CAGE
K123752
Coalign Innovations, Inc.
Orthopedic · 39d