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 Life Spine, Inc., Nu Vasive, Incorporated and SeaSpine Orthopedics Corporation.

891
Total
891
Cleared
129d
Avg days
2007
Since
891 devices
385–408 of 891
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 Oct 26, 2017
NuVasive® Modulus TLIF Interbody System
K172341
Nu Vasive, Incorporated
Orthopedic · 85d
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 03, 2017
The TiBow Expandable Spacer System
K170919
Life Spine, Inc.
Orthopedic · 127d
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
Cleared May 19, 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 284d
Cleared May 10, 2017
MOJAVE Expandable Interbody System
K171097
K2m, Inc.
Orthopedic · 27d
Cleared May 01, 2017
NuVasive CoRoent Ti-C System
K163707
Nu Vasive, Incorporated
Orthopedic · 123d
Cleared Mar 16, 2017
NuVasive Modulus XLIF Interbody System
K163230
Nu Vasive, Incorporated
Orthopedic · 119d
Cleared Feb 22, 2017
SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer
K152022
Globus Medical, Inc.
Orthopedic · 582d