ODP · Class II · 21 CFR 888.3080

FDA Product Code ODP: Intervertebral Fusion Device With Bone Graft, Cervical

FDA product code ODP covers cervical intervertebral fusion devices with bone graft.

These implants are placed between adjacent cervical vertebrae to restore disc height, maintain cervical alignment, and facilitate interbody fusion of the unstable spinal segment. They are used in anterior cervical discectomy and fusion procedures for the treatment of herniated discs, degenerative disc disease, and cervical myelopathy.

ODP devices are Class II medical devices, regulated under 21 CFR 888.3080 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Gbs Commonwealth Co., Ltd., Globus Medical, Inc. and Orthofix, Inc..

348
Total
348
Cleared
144d
Avg days
2008
Since
348 devices
121–144 of 348
Cleared Aug 16, 2019
Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
K192018
Titan Spine, Inc.
Orthopedic · 18d
Cleared Aug 15, 2019
ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System
K191621
Choice Spine, LLC
Orthopedic · 58d
Cleared Jul 30, 2019
Addivation Medical Cervical Interbody System
K190291
Addivation Medical, LLC
Orthopedic · 169d
Cleared Jun 19, 2019
Republic Spine Restore Cervical Interbody Fusion System
K190889
Republic Spine, LLC
Orthopedic · 75d
Cleared Jun 13, 2019
Oyster ACIF Cage
K182608
Silony Medical GmbH
Orthopedic · 265d
Cleared Jun 06, 2019
RIGEL PEEK Anterior Cervical Interbody Fusion System
K190618
MiRus, LLC
Orthopedic · 87d
Cleared Mar 21, 2019
nvc
K190380
Nvision Biomedical Technologies, Inc.
Orthopedic · 30d
Cleared Mar 06, 2019
ChoiceSpine Stealth Cervical Spacer System
K183397
Choicespine, LP
Orthopedic · 89d
Cleared Mar 04, 2019
SCARLET® AC-T Secured Anterior Cervical Cage
K190322
Spineart
Orthopedic · 19d
Cleared Feb 14, 2019
Shoreline Cervical Interbody RT System
K183083
SeaSpine Orthopedics Corporation
Orthopedic · 100d
Cleared Feb 11, 2019
Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device
K183557
Titan Spine, Inc.
Orthopedic · 53d
Cleared Feb 04, 2019
Velofix Interbody Fusion System
K190067
U&I Corporation
Orthopedic · 20d
Cleared Jan 28, 2019
Cervical Spacer
K182477
Additive Implants, LLC
Orthopedic · 140d
Cleared Jan 18, 2019
Tyber Medical PT Interbody Spacer
K182284
Tyber Medical, LLC
Orthopedic · 148d
Cleared Dec 18, 2018
REVEL Spacers
K180909
Globus Medical, Inc.
Orthopedic · 256d
Cleared Nov 16, 2018
Axis Chena Cervical PEEK Spacer System
K181140
Axis Orthopaedics
Orthopedic · 200d
Cleared Nov 08, 2018
Neurostructures Cavetto® [MAX] Cervical Cage System
K181590
Neurostructures, Inc.
Orthopedic · 143d
Cleared Sep 19, 2018
TirboLOX-C Cervical IBFD
K181229
Captiva Spine, Inc.
Orthopedic · 133d
Cleared Aug 29, 2018
ACCUFUSE Cervical System
K181471
Absolute Advantage Medical, LLC
Orthopedic · 86d
Cleared Aug 21, 2018
ATEC Cervical Spacer System
K181435
Alphatec Spine, Inc.
Orthopedic · 81d
Cleared Jul 16, 2018
CxHA PEEK Cervical IBF System
K181115
Innovasis, Inc.
Orthopedic · 80d
Cleared Jul 09, 2018
Curiteva Cervical Interbody Fusion System
K181261
Curiteva, LLC
Orthopedic · 59d
Cleared Jul 06, 2018
Tyber Medical PT Interbody Spacer System
K180590
Tyber Medical, LLC
Orthopedic · 122d
Cleared Jun 27, 2018
HD LifeSciences Cervical IBFD System
K180364
Hd Lifesciences, LLC
Orthopedic · 135d