PMA P200022S009

Device: Simplify Cervical Artificial Disc
Applicant: Nuvasive, Inc.
Product code: MJO
Decision date: 2022-11-02
Generic name: Prosthesis, intervertebral disc
Approval order statement: Approval for the manufacturing site transfer to 805 Liberty Lane, West Carrollton (Dayton), Ohio, and 4670 East Shelby Drive, Memphis, Tennessee, for portions of the manufacturing activities for the Simplify® Cervical Artificial Disc.

Current openFDA PMA Record#

Device: Simplify Cervical Artificial Disc
Applicant: Nuvasive, Inc.
PMA number: P200022
Supplement: S009
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2022-11-02
Decision code: APPR
Date received: 2022-01-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the manufacturing site transfer to 805 Liberty Lane, West Carrollton (Dayton), Ohio, and 4670 East Shelby Drive, Memphis, Tennessee, for portions of the manufacturing activities for the Simplify® Cervical Artificial Disc.