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 Globus Medical, Inc..

353
Total
353
Cleared
144d
Avg days
2008
Since
353 devices
337–353 of 353
Cleared Sep 18, 2009
TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S
K091873
Spineart
Orthopedic · 87d
Cleared Jul 24, 2009
NUBIC AND RABEA DEVICES
K082848
Signus Medizintechnik GmbH
Orthopedic · 298d
Cleared Jul 14, 2009
LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
K091088
Ldr Spine USA
Orthopedic · 90d
Cleared May 27, 2009
SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
K083118
Spinal USA
Orthopedic · 217d
Cleared Apr 20, 2009
CALIX SPINAL IMPLANT SYSTEM
K083637
X-Spine Systems, Inc.
Orthopedic · 132d
Cleared Apr 09, 2009
CAMBRIA
K082309
Seaspine, Inc.
Orthopedic · 239d
Cleared Mar 20, 2009
FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE
K083425
Adaptive Specialty, LLC
Orthopedic · 121d
Cleared Mar 04, 2009
AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
K083311
Aesculap Implant Systems, Inc.
Orthopedic · 114d
Cleared Jan 13, 2009
PHENIX CERVICAL INTERBODY DEVICE
K083167
Spinal Devices, LLC
Orthopedic · 78d
Cleared Dec 22, 2008
PHANTOM PLUS CAGE SYSTEM
K082801
Us Spine
Orthopedic · 89d
Cleared Oct 02, 2008
NUVASIVE COROENT SYSTEM
K081611
Nuvasive, Inc.
Orthopedic · 115d
Cleared Oct 02, 2008
ATLAS SPINE SPACER
K081880
Atlas Spine, Inc.
Orthopedic · 92d
Cleared Sep 19, 2008
NOVEL CERVICAL SPINAL SPACER SYSTEM
K081730
Alphatec Spine, Inc.
Orthopedic · 93d
Cleared Sep 05, 2008
ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES
K081614
Interbody Innovations, Llp
Orthopedic · 88d
Cleared Feb 07, 2008
CIMPLICITY SPINAL SYSTEM
K073320
Spine Smith Partners L.P.
Orthopedic · 73d
Cleared Jan 24, 2008
CRYSTAL
K073351
Spinal Elements, Inc.
Orthopedic · 56d
Cleared Jan 18, 2008
PATRIOT SPACERS: COLONIAL ACDF
K072991
Globus Medical, Inc.
Orthopedic · 87d