PMA P070001S027

Device: prodisc C
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S027
Product code: MJO
Decision date: 2024-08-07
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: approval allowing (1) both Bricon Technology GmbH and Hammill Medical to machine all inlays used in the prodisc -C, -C Vivo, -C SK, and -C Nova and (2) modification to inlay numbering/identification

Current openFDA PMA Record#

Device: prodisc C
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S027
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2024-08-07
Decision code: OK30
Date received: 2024-07-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval allowing (1) both Bricon Technology GmbH and Hammill Medical to machine all inlays used in the prodisc -C, -C Vivo, -C SK, and -C Nova and (2) modification to inlay numbering/identification