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 Orthofix, Inc., Nu Vasive, Incorporated and Medtronic Sofamor Danek USA, Inc..

353
Total
353
Cleared
144d
Avg days
2008
Since
353 devices
313–336 of 353
Cleared Aug 05, 2011
PERIMETER C SPINAL SYSTEM
K100967
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 484d
Cleared Aug 02, 2011
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
K111675
Theken Spine, LLC
Orthopedic · 48d
Cleared Jul 22, 2011
CERVICAL CAGE
K110915
Eisertech, LLC
Orthopedic · 112d
Cleared Jul 19, 2011
PLATEAU SPACER SYSTEM
K111835
Life Spine, Inc.
Orthopedic · 20d
Cleared Jun 30, 2011
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655
Exactech, Inc.
Orthopedic · 197d
Cleared Mar 25, 2011
CAPTIVA SPINE FUSELOX CERVICAL CAGE
K110585
Captiva Spine, Inc.
Orthopedic · 24d
Cleared Mar 14, 2011
STCC
K100698
Cardinal Spine, LLC
Orthopedic · 368d
Cleared Mar 07, 2011
ALEUTTIAN
K103169
K2m, Inc.
Orthopedic · 131d
Cleared Feb 28, 2011
LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K103660
Lanx, Inc.
Orthopedic · 75d
Cleared Feb 11, 2011
BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM
K102449
Bright Spine, Inc.
Orthopedic · 168d
Cleared Jan 25, 2011
ORTHOVITA PEEK SPACER
K101171
Orthovita, Inc.
Orthopedic · 274d
Cleared Jan 10, 2011
TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
K103033
Zimmer Trabecular Metal Technology
Orthopedic · 89d
Cleared Dec 16, 2010
VU CPOD INTERVERTEBRAL BODU FUSION DEVICE
K101363
Musculoskeletal Clinical Regulatory Advisers
Orthopedic · 216d
Cleared Oct 13, 2010
SMALL PLATEAU SPACER SYSTEM
K093093
Life Spine
Orthopedic · 377d
Cleared Sep 27, 2010
CONSTRUX MINI PEEK SPACER SYSTEM
K101812
Orthofix, Inc.
Orthopedic · 90d
Cleared Sep 13, 2010
TRANSCORP ACIF SYSTEM
K092794
Transcorp, Inc.
Orthopedic · 367d
Cleared Jul 29, 2010
ENDOSKELETON TC
K100889
Titan Spine, LLC
Orthopedic · 120d
Cleared Jul 22, 2010
ALEUTIAN IBF SYSTEM
K101302
K2m, Inc.
Orthopedic · 73d
Cleared Jun 25, 2010
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
K100214
Medtronic Sofamor Danek
Orthopedic · 151d
Cleared Mar 16, 2010
IMPIX MANTA CERVICAL INTERBODY DEVICE
K100484
Medicrea
Orthopedic · 26d
Cleared Jan 27, 2010
C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
K092540
Rsb Spine, LLC
Orthopedic · 161d
Cleared Dec 22, 2009
PATHWAY IVB/VBR
K092904
Custom Spine, Inc.
Orthopedic · 92d
Cleared Nov 02, 2009
CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER
K091531
Choice Spine, Llp
Orthopedic · 160d
Cleared Oct 30, 2009
ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES
K090887
SpineCraft
Orthopedic · 213d