PMA P050010S009

Device: PRODISC -L TOTAL DISC REPLACEMENT
Applicant: Centinel Spine, LLC
PMA number: P050010
Supplement: S009
Product code: MJO
Decision date: 2011-10-04
Classification: Prosthesis, Intervertebral Disc
Generic name: Prosthesis, intervertebral disc
Approval order statement: APPROVAL FOR A CHANGE FROM A MANUAL POLISHING PROCESS TO AN AUTOMATED POLISHING PROCESS AND THE ADDITION OF A PASSIVATION PROCESS AFTER THE PLASMA COATING PROCESS.

Current openFDA PMA Record#

Device: PRODISC -L TOTAL DISC REPLACEMENT
Applicant: Centinel Spine, LLC
PMA number: P050010
Supplement: S009
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2011-10-04
Decision code: APPR
Date received: 2010-09-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE FROM A MANUAL POLISHING PROCESS TO AN AUTOMATED POLISHING PROCESS AND THE ADDITION OF A PASSIVATION PROCESS AFTER THE PLASMA COATING PROCESS.