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
169–192 of 891
Cleared Aug 27, 2021
BEE PLIF Cage
K211413
NGMedical GmbH
Orthopedic · 113d
Cleared Aug 20, 2021
IO Expandable Lumbar Interbody Fusion System
K210800
MiRus, LLC
Orthopedic · 157d
Cleared Aug 10, 2021
PSX Interbody System
K211873
Alphatec Spine, Inc.
Orthopedic · 54d
Cleared Aug 05, 2021
Lateral Spine Truss System (LSTS) Interbody Fusion Device
K211388
4Web Medical, Inc.
Orthopedic · 92d
Cleared Jul 07, 2021
Pantheon IBFD
K203003
Pantheon Spinal
Orthopedic · 279d
Cleared Jul 07, 2021
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System
K210497
SeaSpine Orthopedics Corporation
Orthopedic · 135d
Cleared Jun 30, 2021
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
K210044
Spinal Elements, Inc.
Orthopedic · 174d
Cleared Jun 30, 2021
aprevo Transforaminal IBF
K210542
Carlsmed, Inc.
Orthopedic · 126d
Cleared Jun 24, 2021
LABYRINTH
K211306
Zavation Medical Products, LLC
Orthopedic · 56d
Cleared Jun 15, 2021
SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
K210595
Camber Spine Technologies, LLC
Orthopedic · 106d
Cleared Jun 07, 2021
X-Pac Expandable Lumbar Cage System
K203802
Expanding Innovations, Inc.
Orthopedic · 161d
Cleared Jun 02, 2021
SeaSpine WaveForm™ A Interbody System
K210583
SeaSpine Orthopedics Corporation
Orthopedic · 96d
Cleared May 26, 2021
Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System
K211258
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 24, 2021
NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
K210214
Nu Vasive, Incorporated
Orthopedic · 117d
Cleared May 24, 2021
Catalyft PL Expandable Interbody System
K210425
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 102d
Cleared May 12, 2021
NuVasive MOD-EX XLIF Interbody System
K210439
Nu Vasive, Incorporated
Orthopedic · 89d
Cleared May 06, 2021
CONDUIT Instruments
K210728
Medos International SARL
Orthopedic · 56d
Cleared Apr 30, 2021
ProLift Lateral HELO Fixated
K210061
Life Spine, Inc.
Orthopedic · 109d
Cleared Apr 29, 2021
Expandable Titanium PLIF/TLIF System
K201024
Spectrum Spine, LLC
Orthopedic · 374d
Cleared Apr 12, 2021
Idys ALIF 3DTi
K200919
Clariance
Orthopedic · 371d
Cleared Mar 26, 2021
Toro-L Interbody Fusion System
K203038
Integrity Implants, Inc.
Orthopedic · 171d
Cleared Mar 26, 2021
Lucent 3D Spinal System
K203254
Spinal Elements, Inc.
Orthopedic · 142d
Cleared Mar 17, 2021
ProLift Wedge Expandable Spacer System
K203361
Life Spine, Inc.
Orthopedic · 121d
Cleared Mar 10, 2021
Hexanium TLIF
K210359
Spinevision, S.A.S.
Orthopedic · 30d