PMA P050010S025

Device: PRODISC -L TOTAL DISC REPLACEMENT DEVICE
Applicant: Centinel Spine, LLC
PMA number: P050010
Supplement: S025
Product code: MJO
Decision date: 2025-06-04
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: Approval to add Fruh Exton, Pennsylvania as a second packaging location, and addition of a new STERIS (Isomedix Operations Inc.) Chester, New York location to provide sterilization services

Current openFDA PMA Record#

Device: PRODISC -L TOTAL DISC REPLACEMENT DEVICE
Applicant: Centinel Spine, LLC
PMA number: P050010
Supplement: S025
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2025-06-04
Decision code: APPR
Date received: 2024-09-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to add Fruh Exton, Pennsylvania as a second packaging location, and addition of a new STERIS (Isomedix Operations Inc.) Chester, New York location to provide sterilization services