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..

897
Total
897
Cleared
130d
Avg days
2007
Since
897 devices
409–432 of 897
Cleared Oct 26, 2017
NuVasive® Modulus TLIF Interbody System
K172341
Nu Vasive, Incorporated
Orthopedic · 85d
Cleared Oct 26, 2017
SeaSpine Ventura NanoMetalene System
K173022
SeaSpine Orthopedics Corporation
Orthopedic · 28d
Cleared Oct 25, 2017
Cortina™ Lumbar Cage System
K171914
Neurostructures, Inc.
Orthopedic · 121d
Cleared Oct 25, 2017
Ortus™ Expandable Lumbar Interbody Fusion System
K172334
Atlas Spine, Inc.
Orthopedic · 84d
Cleared Oct 23, 2017
Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
K172343
Rti Surgical, Inc.
Orthopedic · 82d
Cleared Oct 11, 2017
NuVasive® Modulus XLIF Interbody System
K172123
Nu Vasive, Incorporated
Orthopedic · 89d
Cleared Oct 05, 2017
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
K171689
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Sep 29, 2017
Calix Lumbar Spinal Implant System
K170119
X-Spine Systems, Inc.
Orthopedic · 259d
Cleared Sep 28, 2017
NuVasive TLX Interbody System
K171633
Nu Vasive, Incorporated
Orthopedic · 118d
Cleared Sep 26, 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K171107
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Sep 19, 2017
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
K172199
Medtronic Sofamor Danek
Orthopedic · 60d
Cleared Sep 15, 2017
FLXfit™
K171519
Expanding Orthopedics, Inc.
Orthopedic · 114d
Cleared Sep 15, 2017
Ti-Diagon Oblique TLIF
K172064
Camber Spine Technologies
Orthopedic · 70d
Cleared Sep 08, 2017
Posterior Spine Truss System (PSTS) Interbody Fusion Device
K171351
4Web, Inc.
Orthopedic · 122d
Cleared Sep 08, 2017
Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)
K171893
Bluestone Synergy
Orthopedic · 74d
Cleared Aug 29, 2017
Altus Spine Titanium Interbody Fusion System
K171329
Altus Partners, LLC
Orthopedic · 116d
Cleared Aug 18, 2017
Duo Lumbar Interbody Fusion Device
K171660
Spineology, Inc.
Orthopedic · 74d
Cleared Aug 11, 2017
ShurFit 2C Lumbar Interbody Fusion System
K171657
Precision Spine, Inc.
Orthopedic · 67d
Cleared Aug 08, 2017
Renovis S141 Lumbar Interbody Fusion System
K170888
Renovis Surgical Technologies
Orthopedic · 134d
Cleared Aug 07, 2017
Anterior Spine Truss System (STS) Interbody Fusion Device
K170851
4Web, Inc.
Orthopedic · 138d
Cleared Aug 03, 2017
The TiBow Expandable Spacer System
K170919
Life Spine, Inc.
Orthopedic · 127d
Cleared Jul 25, 2017
LumFuse-TP
K171630
Precifit Medical, Ltd.
Orthopedic · 53d
Cleared Jul 24, 2017
Rampart L Lumbar Interbody Fusion Device
K171724
Spineology, Inc.
Orthopedic · 42d
Cleared Jul 20, 2017
CONCORDE LIFT
K171425
Medos International SARL
Orthopedic · 66d