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
Stable submission activity - 66 submissions in the last 2 years
Consistent review times:
116d avg (recent)
FDA 510(k) Cleared Intervertebral Fusion Device With Bone Graft, Lumbar Devices (Product Code MAX)
891 devices
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
Cleared
Aug 15, 2025
Atlas Spine Project X Expandable Posterior Lumbar Interbody System
Atlas Spine, Inc.
Orthopedic
50d
Cleared
Aug 05, 2025
PRADO™ Lumbar Interbody Fusion System
Bethesda Medical Devices
Orthopedic
29d
Cleared
Jul 17, 2025
MectaLIF 3D Metal
Medacta International S.A.
Orthopedic
106d
Cleared
Jul 08, 2025
PathLoc Lumbar Interbody Fusion Cage System
L & K Biomed Co., Ltd.
Orthopedic
32d
Cleared
Jul 07, 2025
aprevo® anterior lumbar interbody fusion device
Carlsmed, Inc.
Orthopedic
111d
Cleared
Jul 07, 2025
TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
Life Spine, Inc.
Orthopedic
53d
About Product Code MAX - Regulatory Context
510(k) Submission Activity
891 total 510(k) submissions under product code MAX since 2007, with 891 receiving FDA clearance (average review time: 129 days).
Submission volume has remained relatively stable over the observed period, with 66 submissions in the last 24 months.
FDA 510(k) Review Time - MAX Product Code
FDA review times for MAX submissions have been consistent, averaging 116 days recently vs 130 days historically.
MAX devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →