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., Alphatec Spine, Inc. and SeaSpine Orthopedics Corporation.

886
Total
886
Cleared
130d
Avg days
2007
Since
886 devices
121–144 of 886
Cleared Jul 07, 2021
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System
K210497
SeaSpine Orthopedics Corporation
Orthopedic · 135d
Cleared Jun 30, 2021
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
K210044
Spinal Elements, Inc.
Orthopedic · 174d
Cleared Jun 24, 2021
LABYRINTH
K211306
Zavation Medical Products, LLC
Orthopedic · 56d
Cleared Jun 02, 2021
SeaSpine WaveForm™ A Interbody System
K210583
SeaSpine Orthopedics Corporation
Orthopedic · 96d
Cleared May 26, 2021
Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System
K211258
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 24, 2021
NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
K210214
Nu Vasive, Incorporated
Orthopedic · 117d
Cleared May 24, 2021
Catalyft PL Expandable Interbody System
K210425
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 102d
Cleared May 12, 2021
NuVasive MOD-EX XLIF Interbody System
K210439
Nu Vasive, Incorporated
Orthopedic · 89d
Cleared May 06, 2021
CONDUIT Instruments
K210728
Medos International SARL
Orthopedic · 56d
Cleared Apr 30, 2021
ProLift Lateral HELO Fixated
K210061
Life Spine, Inc.
Orthopedic · 109d
Cleared Mar 26, 2021
Lucent 3D Spinal System
K203254
Spinal Elements, Inc.
Orthopedic · 142d
Cleared Mar 17, 2021
ProLift Wedge Expandable Spacer System
K203361
Life Spine, Inc.
Orthopedic · 121d
Cleared Mar 03, 2021
FORZA Ti Spacer System
K203576
Orthofix, Inc.
Orthopedic · 86d
Cleared Feb 19, 2021
Duo Expandable Interbody Fusion System
K210155
Spineology, Inc.
Orthopedic · 29d
Cleared Feb 02, 2021
INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers
K203278
Globus Medical, Inc.
Orthopedic · 88d
Cleared Jan 12, 2021
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System
K203201
Nu Vasive, Incorporated
Orthopedic · 75d