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
505–528 of 896
Cleared Sep 03, 2013
ARDIS INTERBODY SYSTEM
K131242
Zimmer Spine, Inc.
Orthopedic · 125d
Cleared Aug 20, 2013
STAXX IBL SYSTEM
K131071
Spine Wave, Inc.
Orthopedic · 125d
Cleared Aug 08, 2013
EXPANDABLE LUMBAR INTERBODY SYSTEM
K130820
Nu Vasive, Incorporated
Orthopedic · 136d
Cleared Jul 26, 2013
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
K130478
Globus Medical, Inc.
Orthopedic · 151d
Cleared Jul 25, 2013
CAPSTONE(R) SPINAL SYSTEM
K123027
Medtronic Sofamor Danek, Inc.
Orthopedic · 300d
Cleared Jul 17, 2013
LIFE SPINE PLATEAU SPACER SYSTEM
K131077
Life Spine
Orthopedic · 91d
Cleared Jul 05, 2013
MECTALIF
K131671
Medacta International
Orthopedic · 28d
Cleared Jun 13, 2013
PLATEAU SPACER SYSTEM TITANIUM
K130630
Life Spine, Inc.
Orthopedic · 97d
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 01, 2013
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC
K130434
Exactech, Inc.
Orthopedic · 69d
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 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 Feb 21, 2013
LUCENT
K122967
Spinal Elements, Inc.
Orthopedic · 149d
Cleared Jan 18, 2013
CALIBER SPACERS
K123231
Globus Medical, Inc.
Orthopedic · 94d
Cleared Jan 08, 2013
FALCON SPACER
K123180
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Dec 06, 2012
PATRIOT SPACERS
K122097
Globus Medical, Inc.
Orthopedic · 143d
Cleared Oct 18, 2012
COUGAR LS 15 LATERAL CAGE SYSTEM
K122896
Medos International SARL
Orthopedic · 27d
Cleared Sep 18, 2012
CLYDESDALE SPINAL SYSTEM
K122591
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d