PMA P200022S012

Device: Simplify Disc
Applicant: Nuvasive, Inc.
PMA number: P200022
Supplement: S012
Product code: MJO
Decision date: 2025-02-18
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: changes to the cleaning process of the coated endplates at DOT GmbH to automated cleaning, an added oscillating movement, improved ultrasonic oscillator distribution, and an added rinsing step

Current openFDA PMA Record#

Device: Simplify Disc
Applicant: Nuvasive, Inc.
PMA number: P200022
Supplement: S012
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2025-02-18
Decision code: APPR
Date received: 2023-10-16
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the cleaning process of the coated endplates at DOT GmbH to automated cleaning, an added oscillating movement, improved ultrasonic oscillator distribution, and an added rinsing step