PMA P200022S015

Device: Simplify Cervical Artificial Disc
Applicant: Nuvasive, Inc.
PMA number: P200022
Supplement: S015
Product code: MJO
Decision date: 2025-02-13
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: a change to the mid-process inspection method and strategy, updates to the MicroVu programs for measurement of endplate features, and a change to a mid-process quality control step to assess cleat height using MicroVu probes rather than camera-vision

Current openFDA PMA Record#

Device: Simplify Cervical Artificial Disc
Applicant: Nuvasive, Inc.
PMA number: P200022
Supplement: S015
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2025-02-13
Decision code: OK30
Date received: 2025-01-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to the mid-process inspection method and strategy, updates to the MicroVu programs for measurement of endplate features, and a change to a mid-process quality control step to assess cleat height using MicroVu probes rather than camera-vision