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
97–120 of 891
Cleared May 19, 2023
aprevo® transforaminal lumbar interbody fusion device
K231140
Carlsmed, Inc.
Orthopedic · 28d
Cleared May 16, 2023
Eminent Spine 3D Lumbar Interbody Fusion Systems
K230219
Eminent Spine, LLC
Orthopedic · 110d
Cleared May 09, 2023
SIRION Lateral Lumbar Interbody System
K223335
Astura Medical
Orthopedic · 189d
Cleared May 04, 2023
ProLift Micro Expandable Spacer System
K223430
Life Spine, Inc.
Orthopedic · 171d
Cleared Apr 26, 2023
PYXIS 3D Titanium Cage System
K223868
GS Medical Co., Ltd.
Orthopedic · 124d
Cleared Mar 29, 2023
Calibrate LTX Interbody System
K223611
Alphatec Spine, Inc.
Orthopedic · 117d
Cleared Mar 17, 2023
DeGen Impulse AM™ System
K223418
Degen Medical
Orthopedic · 127d
Cleared Mar 08, 2023
CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments
K223688
Medos International S?rl
Orthopedic · 89d
Cleared Mar 03, 2023
PEEK Spinal Infusion Cage
K223776
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Orthopedic · 77d
Cleared Feb 14, 2023
X-Pac Expandable LLIF Cage System
K223174
Expanding Innovations, Inc.
Orthopedic · 126d
Cleared Jan 13, 2023
PathLoc-TA Expandable Lumbar Cage System
K223474
L & K Biomed Co., Ltd.
Orthopedic · 56d
Cleared Jan 06, 2023
LumiVy™ Lumbar IBF System
K223412
Vy Spine, LLC
Orthopedic · 58d
Cleared Jan 05, 2023
CONDUIT LLIF Straight Inserters
K223671
Enztec Limited
Orthopedic · 29d
Cleared Dec 28, 2022
Medussa-PL Cage
K223654
Medyssey USA, Inc.
Orthopedic · 22d
Cleared Dec 19, 2022
4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
K213653
Solco Biomedical Company India Private Limited
Orthopedic · 395d
Cleared Dec 16, 2022
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
K223153
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
Cleared Dec 16, 2022
Hexanium PLIF
K223251
Spinevision, S.A.S.
Orthopedic · 56d
Cleared Dec 08, 2022
Southern Transforaminal Lumbar Interbody Fusion (TLIF)
K221182
Southern Medical (Pty) , Ltd.
Orthopedic · 227d
Cleared Dec 05, 2022
TruLift Lateral Expandable Spacer System & Lateral Plate System
K221806
Life Spine, Inc.
Orthopedic · 166d
Cleared Nov 18, 2022
Calibrate LTX Interbody System
K222455
Alphatec Spine, Inc.
Orthopedic · 95d
Cleared Nov 07, 2022
WaveForm A Interbody System
K222732
SeaSpine Orthopedics Corporation
Orthopedic · 59d
Cleared Nov 03, 2022
ABTross ALIF Expandable Cage System
K221719
Aegis Spine, Inc.
Orthopedic · 143d
Cleared Oct 26, 2022
Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
K223065
Adcura, Inc.
Orthopedic · 26d
Cleared Oct 18, 2022
DualXSLIM(R) T/PLIF
K222203
Amplify Surgical, Inc.
Orthopedic · 85d