PMA P070001S028

Device: prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S028
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 C, prodisc C Vivo, prodisc C Nova, prodisc C SK
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S028
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