PMA P060023S001
- Device
- BRYAN CERVICAL DISC
- Applicant
- Companion Spine France Sas
- PMA number
- P060023
- Supplement
- S001
- Product code
- MJO
- Decision date
- 2012-03-09
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR A MODIFIED SURGICAL TECHNIQUE, NEW INSTRUMENTATION, AND MODIFIED LABELING TO INCLUDE INFORMATION ON MRI COMPATIBILITY OF THE IMPLANTED DEVICE.
Current openFDA PMA Record#
- Device
- BRYAN CERVICAL DISC
- Applicant
- Companion Spine France Sas
- PMA number
- P060023
- Supplement
- S001
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2012-03-09
- Decision code
- APPR
- Date received
- 2010-05-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFIED SURGICAL TECHNIQUE, NEW INSTRUMENTATION, AND MODIFIED LABELING TO INCLUDE INFORMATION ON MRI COMPATIBILITY OF THE IMPLANTED DEVICE.