PMA P110009S007

Device
LDR SPINE MOBI-C CERVICAL DISC PROSTHESIS (TWO LEVEL INDICATION)
Applicant
Highridge Medical, LLC
PMA number
P110009
Supplement
S007
Product code
MJO
Decision date
2014-07-23
Classification
Prosthesis, Intervertebral Disc
Generic name
Prosthesis, intervertebral disc
Approval order statement
ADD BACK-UP EQUIPMENT TO A MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device
LDR SPINE MOBI-C CERVICAL DISC PROSTHESIS (TWO LEVEL INDICATION)
Applicant
Highridge Medical, LLC
PMA number
P110009
Supplement
S007
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2014-07-23
Decision code
OK30
Date received
2014-06-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADD BACK-UP EQUIPMENT TO A MANUFACTURING PROCESS.