PMA P070001S013

Device: SYNTHES PRODISC-C TOTAL DISC REPLACEMENT
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S013
Product code: MJO
Decision date: 2014-08-27
Classification: Prosthesis, Intervertebral Disc
Generic name: Prosthesis, intervertebral disc
Approval order statement: APPROVAL FOR A CHANGE TO THE METHOD USED FOR ESTABLISHMENT OF THE BIOBURDEN ALERT AND ACTION LEVELS FOR DOSE AUDITING OF SYNTHES PRODISC-C AND PRODISC-L TOTAL DISC REPLACEMENT DEVICES.

Current openFDA PMA Record#

Device: SYNTHES PRODISC-C TOTAL DISC REPLACEMENT
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S013
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2014-08-27
Decision code: APPR
Date received: 2014-04-03
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE METHOD USED FOR ESTABLISHMENT OF THE BIOBURDEN ALERT AND ACTION LEVELS FOR DOSE AUDITING OF SYNTHES PRODISC-C AND PRODISC-L TOTAL DISC REPLACEMENT DEVICES.