BRYAN CERVICAL DISC PROSTHESIS
FDA premarket approval P060023 · decided 2009-05-12
Approval details
- PMA number
- P060023
- Trade name
- BRYAN CERVICAL DISC PROSTHESIS
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Companion Spine France Sas
- Date received
- 2006-06-29
- Decision date
- 2009-05-12
- Days to decision
- 1048 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac
- 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
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