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
Cleared
Sep 10, 2021
Explorer TO System
SeaSpine Orthopedics Corporation
Orthopedic
29d
Cleared
Sep 01, 2021
EndoLIF Delta-Cage and DoubleWedge-Cage
Joimax GmbH
Orthopedic
335d
Cleared
Aug 30, 2021
Impulse AM Interbody Fusion System
Degen Medical
Orthopedic
229d
Cleared
Aug 30, 2021
KMTI S141 Lumbar Interbody Fusion System
Kyocera Medical Technologies, Inc.
Orthopedic
59d
Cleared
Aug 27, 2021
BEE PLIF Cage
NGMedical GmbH
Orthopedic
113d
Cleared
Aug 20, 2021
IO Expandable Lumbar Interbody Fusion System
MiRus, LLC
Orthopedic
157d
Cleared
Aug 10, 2021
PSX Interbody System
Alphatec Spine, Inc.
Orthopedic
54d
Cleared
Aug 05, 2021
Lateral Spine Truss System (LSTS) Interbody Fusion Device
4Web Medical, Inc.
Orthopedic
92d
Cleared
Jul 07, 2021
Pantheon IBFD
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
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
Spinal Elements, Inc.
Orthopedic
174d
Cleared
Jun 30, 2021
aprevo Transforaminal IBF
Carlsmed, Inc.
Orthopedic
126d
Cleared
Jun 24, 2021
LABYRINTH
Zavation Medical Products, LLC
Orthopedic
56d
Cleared
Jun 15, 2021
SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
Camber Spine Technologies, LLC
Orthopedic
106d
Cleared
Jun 07, 2021
X-Pac Expandable Lumbar Cage System
Expanding Innovations, Inc.
Orthopedic
161d
Cleared
Jun 02, 2021
SeaSpine WaveForm™ A Interbody System
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
Medtronic Sofamor Danek USA, Inc.
Orthopedic
30d
Cleared
May 24, 2021
NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
Nu Vasive, Incorporated
Orthopedic
117d
Cleared
May 24, 2021
Catalyft PL Expandable Interbody System
Medtronic Sofamor Danek USA, Inc.
Orthopedic
102d
Cleared
May 12, 2021
NuVasive MOD-EX XLIF Interbody System
Nu Vasive, Incorporated
Orthopedic
89d
Cleared
May 06, 2021
CONDUIT Instruments
Medos International SARL
Orthopedic
56d
Cleared
Apr 30, 2021
ProLift Lateral HELO Fixated
Life Spine, Inc.
Orthopedic
109d
Cleared
Apr 29, 2021
Expandable Titanium PLIF/TLIF System
Spectrum Spine, LLC
Orthopedic
374d
Cleared
Apr 12, 2021
Idys ALIF 3DTi
Clariance
Orthopedic
371d