PMA P050010S002

Device
PRODISC L TOTAL DISC REPLACEMENT
Applicant
Centinel Spine, LLC
PMA number
P050010
Supplement
S002
Product code
MJO
Decision date
2008-10-14
Generic name
Prosthesis, intervertebral disc
Approval order statement
APPROVAL FOR CHANGES TO THE MILLING FEED RATE AND TOOL SPEED FOR PROCESSES FOR THE PRODISC-L.

Current openFDA PMA Record#

Device
PRODISC L TOTAL DISC REPLACEMENT
Applicant
Centinel Spine, LLC
PMA number
P050010
Supplement
S002
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2008-10-14
Decision code
APPR
Date received
2008-05-29
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR CHANGES TO THE MILLING FEED RATE AND TOOL SPEED FOR PROCESSES FOR THE PRODISC-L.