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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBRYAN CERVICAL DISC PROSTHESIS
Classification Nameprosthesis, intervertebral disc
ApplicantMEDTRONIC SOFAMOR DANEK USA, INC.
PMA NumberP060023
Date Received06/29/2006
Decision Date05/12/2009
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 09M-0243
Notice Date 05/27/2009
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 radiculopathy and/or myelopathy is defined as any combination of the following: disc herniation with radiculopathy. Spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy resulting in impaired function and at least one clinical neurological sign associated with the cervical level to be treated, and necessitating surgery as demonstrated using computed tomography (ct), myelography and ct, and/or magnetic resonance imaging (mr1). Patients receiving the bryan cervical disc should have failed at least six weeks of non-operative treatment prior to implantation of the bryan cervical disc.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 
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