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
457–480 of 896
Cleared Aug 06, 2015
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System
K151374
Nu Vasive, Incorporated
Orthopedic · 76d
Cleared Jul 22, 2015
Rampart-T Interbody Fusion System
K151020
Spineology, Inc.
Orthopedic · 97d
Cleared Jul 09, 2015
Leva Spacer System
K151581
Spine Wave, Inc.
Orthopedic · 28d
Cleared Jun 18, 2015
DePuy Synthes T-PAL Ti Spacer
K151276
Synthes USA Products, LLC
Orthopedic · 36d
Cleared Jun 11, 2015
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K150135
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 141d
Cleared Jun 09, 2015
ELEVATE Spinal System
K142559
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 271d
Cleared May 22, 2015
Battalion Universal Spacer System
K143740
Alphatec Spine, Inc.
Orthopedic · 143d
Cleared May 19, 2015
Lucent
K150061
Spinal Elements, Inc.
Orthopedic · 126d
Cleared May 11, 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152
Exactech, Inc.
Orthopedic · 108d
Cleared Apr 29, 2015
NuVasive(R) CCX-L Interbody System
K143595
Nu Vasive, Incorporated
Orthopedic · 132d
Cleared Mar 13, 2015
NuVasive CoRoent System
K141665
Nuvasive, Inc.
Orthopedic · 263d
Cleared Mar 05, 2015
AccuLIF TL and PL Cage
K143616
Stryker Corporation
Orthopedic · 76d
Cleared Mar 05, 2015
Leva(TM) Spacer System
K150285
Spine Wave, Inc.
Orthopedic · 28d
Cleared Feb 12, 2015
Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)
K143297
Zimmer Spine, Inc.
Orthopedic · 87d
Cleared Jan 26, 2015
LEVA (TM) SPACER SYSTEM
K141980
Spine Wave, Inc.
Orthopedic · 189d
Cleared Dec 01, 2014
JULIET LL
K141135
Spineart
Orthopedic · 214d
Cleared Nov 20, 2014
COROENT SYSTEM
K141896
Nu Vasive, Incorporated
Orthopedic · 129d
Cleared Oct 23, 2014
ABACUS (TM) SPACER SYSTEM
K142101
Spine Wave, Inc.
Orthopedic · 83d
Cleared Oct 14, 2014
JULIET PO
K142277
Spineart
Orthopedic · 60d
Cleared Oct 09, 2014
COROENT TI-C SYSTEM
K140319
Nuvasive, Inc.
Orthopedic · 241d
Cleared Sep 26, 2014
CLYDESDALE(R) SPINAL SYSTEM
K133577
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 309d
Cleared Sep 19, 2014
LONGBOW SPACER SYSTEM
K133717
Life Spine
Orthopedic · 288d
Cleared Jul 25, 2014
MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM
K140770
Nu Vasive, Incorporated
Orthopedic · 120d
Cleared Jul 16, 2014
ACCULIF TL AND PL CAGE
K141217
Stryker Corporation
Orthopedic · 65d