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
Declining activity -
57 submissions in the last 2 years
vs 74 in the prior period
Consistent review times:
114d avg (recent)
FDA 510(k) Cleared Intervertebral Fusion Device With Bone Graft, Lumbar Devices (Product Code MAX)
897 devices
Cleared
Aug 20, 2026
SCALA® TL
Spineart SA
Orthopedic
142d
Cleared
Jul 28, 2026
TruLift Expandable System
Life Spine, Inc.
Orthopedic
89d
Cleared
Jul 17, 2026
Catalyft PL Expandable Interbody System
Medtronic Sofamor Danek USA, Inc.
Orthopedic
301d
Cleared
Jul 14, 2026
Symmetrix™ L Spinal System
Medtronic Sofamor Danek USA, Inc.
Orthopedic
109d
Cleared
Jul 01, 2026
Admiral ACP System
SeaSpine Orthopedics Corporation
Orthopedic
273d
Cleared
Jun 15, 2026
Fule Interbody Fusion Cage System
Beijing Fule Science & Technology Development Co., Ltd.
Orthopedic
262d
Cleared
May 29, 2026
Exceed® Biplanar Expandable Interbody System
Spine Wave, Inc.
Orthopedic
51d
Cleared
May 28, 2026
BMD Titanium Spinal Fusion System
Global Biomedica s.r.o.
Orthopedic
175d
Cleared
May 15, 2026
Ventana® P/T Lumbar Interbody System
Spinal Elements, Inc.
Orthopedic
87d
Cleared
May 12, 2026
VersaLift Expandable System
Life Spine, Inc.
Orthopedic
60d
Cleared
May 09, 2026
aprevo® anterior and lateral lumbar interbody system
Carlsmed, Inc.
Orthopedic
92d
Cleared
Apr 30, 2026
BEE PLIF Cage
NGMedical GmbH
Orthopedic
29d
Cleared
Apr 29, 2026
SCRIPT™ Implant System
Globus Medical, Inc.
Orthopedic
211d
Cleared
Feb 26, 2026
SWINGO-3D Lumbar Cage System
Implanet
Orthopedic
73d
Cleared
Feb 23, 2026
LUX Expandable Lumbar Interbody System
Xenix Medical
Orthopedic
98d
Cleared
Feb 04, 2026
Luna® Ti Interbody Fusion System
Spinal Elements, Inc.
Orthopedic
327d
Cleared
Jan 23, 2026
Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System
Life Spine, Inc.
Orthopedic
59d
Cleared
Jan 08, 2026
Titanium Interbody System
Spine Innovation, LLC
Orthopedic
101d
Cleared
Dec 19, 2025
IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
Medicrea International S.A.S. (Medtronic)
Orthopedic
32d
Cleared
Nov 25, 2025
ZSFab Lumbar Interbody System
Zsfab, Inc.
Orthopedic
99d
Cleared
Oct 28, 2025
UniSpace® TPLIF Cage
Cg Medtech Co., Ltd.
Orthopedic
91d
Cleared
Oct 24, 2025
Expandable Titanium PLIF/TLIF System
Spectrum Spine, Inc.
Orthopedic
24d
Cleared
Sep 18, 2025
Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF))
Mobarn Medical Devices, LLC
Orthopedic
128d
Cleared
Sep 04, 2025
Endoskeleton™ Interbody Systems
Medtronic Sofamor Danek USA, Inc.
Orthopedic
118d
About Product Code MAX - Regulatory Context
510(k) Submission Activity
897 total 510(k) submissions under product code MAX since 2007, with 897 receiving FDA clearance (average review time: 130 days).
Submission volume has declined in recent years - 57 submissions in the last 24 months compared to 74 in the prior period.
FDA 510(k) Review Time - MAX Product Code
FDA review times for MAX submissions have been consistent, averaging 114 days recently vs 131 days historically.
MAX devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →