Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBRYAN CERVICAL DISC PROSTHESIS
Generic NameProsthesis, intervertebral disc
ApplicantCompanion Spine France S.A.S
Immeuble le Bridge 3
5 Allee des Acacias
Merignac 33 70
PMA NumberP060023
Date Received06/29/2006
Decision Date05/12/2009
Product Code MJO 
Docket Number 09M-0243
Notice Date 05/27/2009
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE BRYAN CERVICAL DISC. THE DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY.THE BRYAN DEVICE IS IMPLANTED VIA AN OPEN ANTERIOR APPROACH. INTRACTABLE RADICULOPATHYAND/OR MYELOPATHY IS DEFINED AS ANY COMBINATION OF THE FOLLOWING: DISC HERNIATION WITHRADICULOPATHY. SPONDYLOTIC RADICULOPATHY, DISC HERNIATION WITH MYELOPATHY, OR SPONDYLOTICMYELOPATHY RESULTING IN IMPAIRED FUNCTION AND AT LEAST ONE CLINICAL NEUROLOGICAL SIGN ASSOCIATEDWITH THE CERVICAL LEVEL TO BE TREATED, AND NECESSITATING SURGERY AS DEMONSTRATED USING COMPUTEDTOMOGRAPHY (CT), MYELOGRAPHY AND CT, AND/OR MAGNETIC RESONANCE IMAGING (MR1). PATIENTSRECEIVING THE BRYAN CERVICAL DISC SHOULD HAVE FAILED AT LEAST SIX WEEKS OF NON-OPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE BRYAN CERVICAL DISC.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S008 
-
-