PMA P070001S015

Device: PRODISC-C TOTAL DISC REPLACEMENT
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S015
Product code: MJO
Decision date: 2017-07-27
Classification: Prosthesis, Intervertebral Disc
Generic name: Prosthesis, intervertebral disc
Approval order statement: Change to the holding fixture and coordinate measuring machine (CMM) software programs used to dimensionally inspect the ProDisc-C Total Disc Replacement inferior and superior plates.

Current openFDA PMA Record#

Device: PRODISC-C TOTAL DISC REPLACEMENT
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S015
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2017-07-27
Decision code: OK30
Date received: 2017-06-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the holding fixture and coordinate measuring machine (CMM) software programs used to dimensionally inspect the ProDisc-C Total Disc Replacement inferior and superior plates.