PMA P100003S006

Device: SECURE -C CERVICAL ARTIFICIAL DISC
Applicant: Globus Medical, Inc.
PMA number: P100003
Supplement: S006
Product code: MJO
Decision date: 2016-05-17
Generic name: Prosthesis, intervertebral disc
Approval order statement: Approval for clarifying the worst-case temperature rise for the subject device and revising the labeling to adequately reflect those temperature. The Secure-C Cervical Artificial Disc can be now be labeled as MR Compatible.

Current openFDA PMA Record#

Device: SECURE -C CERVICAL ARTIFICIAL DISC
Applicant: Globus Medical, Inc.
PMA number: P100003
Supplement: S006
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2016-05-17
Decision code: APPR
Date received: 2015-07-01
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for clarifying the worst-case temperature rise for the subject device and revising the labeling to adequately reflect those temperature. The Secure-C Cervical Artificial Disc can be now be labeled as MR Compatible.