PMA P100003S001
- Device
- SECURE -C CERVICAL ARTIFICIAL DISC
- Applicant
- Globus Medical, Inc.
- PMA number
- P100003
- Supplement
- S001
- Product code
- MJO
- Decision date
- 2013-03-15
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR A MINOR MODIFICATION OF THE NARROW IMPLANT HOLDER (PART #614.805).
Current openFDA PMA Record#
- Device
- SECURE -C CERVICAL ARTIFICIAL DISC
- Applicant
- Globus Medical, Inc.
- PMA number
- P100003
- Supplement
- S001
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2013-03-15
- Decision code
- APPR
- Date received
- 2013-02-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A MINOR MODIFICATION OF THE NARROW IMPLANT HOLDER (PART #614.805).