PMA P100003S007
- Device
- SECURE-C CERVICAL ARTIFICIAL DISC
- Applicant
- Globus Medical, Inc.
- PMA number
- P100003
- Supplement
- S007
- Product code
- MJO
- Decision date
- 2017-08-18
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for updated labeling to reflect seven (7) year data.
Current openFDA PMA Record#
- Device
- SECURE-C CERVICAL ARTIFICIAL DISC
- Applicant
- Globus Medical, Inc.
- PMA number
- P100003
- Supplement
- S007
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2017-08-18
- Decision code
- APPR
- Date received
- 2016-12-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updated labeling to reflect seven (7) year data.