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
529–552 of 897
Cleared Jan 06, 2016
Amendia Interbody Fusion Devices
K151310
Amendia, Inc.
Orthopedic · 233d
Cleared Dec 15, 2015
AccuLIF TL and PL Cage
K152651
Stryker Corporation
Orthopedic · 90d
Cleared Dec 11, 2015
VariLift-L Interbody Fusion Device
K151900
Wenzel Spine, Inc.
Orthopedic · 154d
Cleared Dec 10, 2015
Twin Peaks Lumbar Interbody Fusion System
K152355
Spineway
Orthopedic · 112d
Cleared Nov 20, 2015
CONCORDE Bullet Lumbar Interbody System
K151773
Medos International SARL
Orthopedic · 143d
Cleared Nov 19, 2015
InFill Interbody Fusion Device
K152259
Pinnacle Spine Group, LLC
Orthopedic · 100d
Cleared Nov 19, 2015
Tritanium PL Cage
K152304
Stryker
Orthopedic · 97d
Cleared Nov 13, 2015
PIVOX(tm) Oblique Lateral Spinal System
K152277
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 93d
Cleared Nov 10, 2015
Integrity Spine Lumbar Interbody Fusion System
K151819
Integrity Spine Lumbar Interbody Fusion System
Orthopedic · 127d
Cleared Oct 19, 2015
Opticage Expandable Interbody Fusion Device
K152156
Interventional Spine, Inc.
Orthopedic · 77d
Cleared Oct 14, 2015
Px HA PEEK IBF System
K151785
Innovasis, Inc.
Orthopedic · 105d
Cleared Oct 08, 2015
CONCORDE Bullet Spinal System
K151352
Medos International SARL
Orthopedic · 141d
Cleared Oct 02, 2015
Valeo Spacer System and Valeo II Interbody Fusion Device System
K143518
Amedica Corp.
Orthopedic · 294d
Cleared Oct 02, 2015
LOSPA IS Spinal System
K151408
Corentec Co., Ltd.
Orthopedic · 129d
Cleared Sep 25, 2015
Bluefin Interbody System
K143479
Tides Medical
Orthopedic · 291d
Cleared Sep 10, 2015
Amendia Interbody Fusion Devices
K151322
Amendia, Inc.
Orthopedic · 115d
Cleared Sep 10, 2015
NuVasive CoRoent Lumbar System
K151472
Nu Vasive, Incorporated
Orthopedic · 101d
Cleared Aug 21, 2015
STERISPINE LC CAGE
K151756
Safe Orthopaedics
Orthopedic · 53d
Cleared Aug 20, 2015
Cascadia Interbody System
K150481
K2m, Inc.
Orthopedic · 177d
Cleared Aug 18, 2015
LnK Lumbar Interbody Fusion Cage System
K151140
L & K Biomed Co., Ltd.
Orthopedic · 111d
Cleared Aug 13, 2015
Aesculap T-Space PEEK and XP Spinal System
K151056
Aesculap Implant Systems, LLC
Orthopedic · 115d
Cleared Aug 10, 2015
Omega LIF System
K150395
Amendia, Inc.
Orthopedic · 173d
Cleared Aug 06, 2015
CAPSTONE Spinal System, CLYDESDALE Spinal System
K151128
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 100d
Cleared Aug 06, 2015
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System
K151374
Nu Vasive, Incorporated
Orthopedic · 76d