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
385–408 of 896
Cleared Jan 19, 2018
Reliance Lumbar IBF System
K173283
Reliance Medical Systems, LLC
Orthopedic · 95d
Cleared Jan 18, 2018
Tritanium® TL Curved Posterior Lumbar Cage
K173476
Stryker
Orthopedic · 70d
Cleared Jan 03, 2018
Juliet Ti LL
K173702
Spineart
Orthopedic · 30d
Cleared Dec 21, 2017
FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers
K171848
Globus Medical, Inc.
Orthopedic · 183d
Cleared Dec 20, 2017
ProLift® Expandable System
K173182
Life Spine, Inc.
Orthopedic · 82d
Cleared Dec 14, 2017
Cascadia Interbody System
K172009
K2m, Inc.
Orthopedic · 164d
Cleared Dec 06, 2017
Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System
K173153
Nu Vasive, Incorporated
Orthopedic · 68d
Cleared Dec 04, 2017
SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica
K173260
SeaSpine Orthopedics Corporation
Orthopedic · 55d
Cleared Nov 29, 2017
Lucent®
K170235
Spinal Elements, Inc.
Orthopedic · 308d
Cleared Nov 29, 2017
Arlington PLIF/TLIF Cage
K172020
Signature Orthopaedics Pty, Ltd.
Orthopedic · 147d
Cleared Oct 26, 2017
NuVasive® Modulus TLIF Interbody System
K172341
Nu Vasive, Incorporated
Orthopedic · 85d
Cleared Oct 26, 2017
SeaSpine Ventura NanoMetalene System
K173022
SeaSpine Orthopedics Corporation
Orthopedic · 28d
Cleared Oct 11, 2017
NuVasive® Modulus XLIF Interbody System
K172123
Nu Vasive, Incorporated
Orthopedic · 89d
Cleared Oct 05, 2017
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
K171689
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Sep 28, 2017
NuVasive TLX Interbody System
K171633
Nu Vasive, Incorporated
Orthopedic · 118d
Cleared Sep 26, 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K171107
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Sep 19, 2017
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
K172199
Medtronic Sofamor Danek
Orthopedic · 60d
Cleared Aug 18, 2017
Duo Lumbar Interbody Fusion Device
K171660
Spineology, Inc.
Orthopedic · 74d
Cleared Aug 03, 2017
The TiBow Expandable Spacer System
K170919
Life Spine, Inc.
Orthopedic · 127d
Cleared Jul 24, 2017
Rampart L Lumbar Interbody Fusion Device
K171724
Spineology, Inc.
Orthopedic · 42d
Cleared Jul 20, 2017
CONCORDE LIFT
K171425
Medos International SARL
Orthopedic · 66d
Cleared Jul 06, 2017
CRESCENT™ Spinal System
K171031
Medtronic Sofamor Danek
Orthopedic · 91d
Cleared Jun 26, 2017
NuVasive® CoRoent® Thoracolumbar System
K170962
Nu Vasive, Incorporated
Orthopedic · 87d
Cleared Jun 13, 2017
FUSE Spinal System
K171468
Medtronic Sofamor Danek
Orthopedic · 26d