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 Nu Vasive, Incorporated, Medtronic Sofamor Danek USA, Inc. and Life Spine, Inc..

896
Total
896
Cleared
130d
Avg days
2007
Since
896 devices
145–168 of 896
Cleared Apr 28, 2022
EARP Interbody System
K212477
Nvision Biomedical Technologies, Inc.
Orthopedic · 262d
Cleared Apr 12, 2022
Ti3Z Lumbar Interbody System
K212811
Zavation Medical Products, LLC
Orthopedic · 221d
Cleared Apr 12, 2022
Anteralign Spinal System with Titan nanoLOCK Surface Technology
K214010
Medtronic Sofamor Danek USA
Orthopedic · 111d
Cleared Mar 25, 2022
Toro-L Interbody Fusion System
K213355
Integrity Implants, Inc.
Orthopedic · 164d
Cleared Mar 24, 2022
FlareHawk Interbody Fusion System
K220453
Integrity Implants, Inc.
Orthopedic · 35d
Cleared Mar 24, 2022
X-Pac Expandable Lumbar Cage System
K220655
Expanding Innovations, Inc.
Orthopedic · 17d
Cleared Mar 09, 2022
PathLoc Lumbar Interbody Fusion Cage System
K213441
L & K Biomed Co., Ltd.
Orthopedic · 135d
Cleared Mar 09, 2022
Genesys Spine 3DP Lumbar Interbody System
K220096
Genesys Spine
Orthopedic · 56d
Cleared Feb 16, 2022
LumiVy Lumbar IBF System
K212930
Vy Spine, LLC
Orthopedic · 155d
Cleared Jan 05, 2022
FORZA XP Expandable Spacer System
K213951
Orthofix US, LLC
Orthopedic · 19d
Cleared Dec 23, 2021
NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty
K203714
Nu Vasive, Incorporated
Orthopedic · 367d
Cleared Dec 08, 2021
ShurFit Lumbar Interbody System
K212075
Precision Spine, Inc.
Orthopedic · 159d
Cleared Dec 08, 2021
Anteralign Spinal System with Titan nanoLOCK Surface Technology
K212524
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 119d
Cleared Dec 01, 2021
NGM WAVE PLIF Cage
K212050
NGMedical GmbH
Orthopedic · 154d
Cleared Nov 19, 2021
Catalyft LS Expandable Interbody System
K212653
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Nov 16, 2021
Deploy Expandable Interbody System
K211845
Southern Spine, LLC
Orthopedic · 154d
Cleared Nov 01, 2021
DePuy CONDUIT LLIF Angled Inserters
K212823
Enztec Limited
Orthopedic · 59d
Cleared Oct 29, 2021
Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF
K212389
Intelivation, LLC
Orthopedic · 88d
Cleared Oct 29, 2021
MectaLIF Extension
K212831
Medacta International S.A.
Orthopedic · 52d
Cleared Oct 08, 2021
ProLift Micro Expandable Spacer System
K212520
Life Spine, Inc.
Orthopedic · 59d
Cleared Sep 29, 2021
DualX
K211740
Amplify Surgical, Inc.
Orthopedic · 114d
Cleared Sep 22, 2021
IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System
K211805
Alphatec Spine, Inc.
Orthopedic · 103d
Cleared Sep 21, 2021
KEYSTONE PEEK Cage System
K211689
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 111d
Cleared Sep 14, 2021
Kleiner KG2 System
K211474
BAAT Medical Products B.V.
Orthopedic · 125d