PMA P100003S003

Device
SECURE -C CERVICAL ARTIFICIAL DISC
Applicant
Globus Medical, Inc.
PMA number
P100003
Supplement
S003
Product code
MJO
Decision date
2014-05-08
Generic name
Prosthesis, intervertebral disc
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
SECURE -C CERVICAL ARTIFICIAL DISC
Applicant
Globus Medical, Inc.
PMA number
P100003
Supplement
S003
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2014-05-08
Decision code
APPR
Date received
2013-06-21
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.