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
577–600 of 897
Cleared Mar 12, 2015
Biomet Spine Fusion System
K142634
Biomet Spine, LLC
Orthopedic · 176d
Cleared Mar 05, 2015
AccuLIF TL and PL Cage
K143616
Stryker Corporation
Orthopedic · 76d
Cleared Mar 05, 2015
Leva(TM) Spacer System
K150285
Spine Wave, Inc.
Orthopedic · 28d
Cleared Feb 12, 2015
Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)
K143297
Zimmer Spine, Inc.
Orthopedic · 87d
Cleared Feb 06, 2015
Renovis S141 Lumbar Interbody Cage System
K143126
Renovis Surgical Technologies
Orthopedic · 98d
Cleared Jan 26, 2015
LEVA (TM) SPACER SYSTEM
K141980
Spine Wave, Inc.
Orthopedic · 189d
Cleared Dec 18, 2014
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene
K142488
Seaspine, Inc.
Orthopedic · 105d
Cleared Dec 01, 2014
JULIET LL
K141135
Spineart
Orthopedic · 214d
Cleared Nov 28, 2014
nva, nvp, nvt
K142594
Nvision Biomedical Technologies, LLC
Orthopedic · 74d
Cleared Nov 24, 2014
OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE
K140716
Interventional Spine, Inc.
Orthopedic · 248d
Cleared Nov 20, 2014
COROENT SYSTEM
K141896
Nu Vasive, Incorporated
Orthopedic · 129d
Cleared Nov 20, 2014
LUNA INTERBODY SYSTEM
K142023
Benvenue Medical, Inc.
Orthopedic · 118d
Cleared Nov 18, 2014
Amedica Valeo II Interbody Fusion Device
K142347
Amedica Corp.
Orthopedic · 88d
Cleared Oct 27, 2014
ENDOSKELETON
K141953
Titan Spine, LLC
Orthopedic · 101d
Cleared Oct 23, 2014
ABACUS (TM) SPACER SYSTEM
K142101
Spine Wave, Inc.
Orthopedic · 83d
Cleared Oct 17, 2014
Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL
K142589
Titan Spine, LLC
Orthopedic · 32d
Cleared Oct 15, 2014
COGENT MED-LIF XL
K142193
Cogent Spine, LLC
Orthopedic · 65d
Cleared Oct 14, 2014
JULIET PO
K142277
Spineart
Orthopedic · 60d
Cleared Oct 09, 2014
COROENT TI-C SYSTEM
K140319
Nuvasive, Inc.
Orthopedic · 241d
Cleared Oct 01, 2014
INNESIS PEEK TL CAGE
K140577
Bk Meditech, Co., Ltd.
Orthopedic · 209d
Cleared Sep 26, 2014
CLYDESDALE(R) SPINAL SYSTEM
K133577
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 309d
Cleared Sep 23, 2014
4WEB SPINAL IMPLANT PRODUCTS
K142112
4Web, Inc.
Orthopedic · 50d
Cleared Sep 19, 2014
LONGBOW SPACER SYSTEM
K133717
Life Spine
Orthopedic · 288d
Cleared Sep 16, 2014
MOBIS II ST SPINAL IMPLANT
K141405
Signus Medizintechnik GmbH
Orthopedic · 111d