PMA P200022S016

Device: Simplify® Cervical Artificial Disc
Applicant: Nuvasive, Inc.
PMA number: P200022
Supplement: S016
Product code: MJO
Decision date: 2025-06-05
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: approval for elimination of (1) component level inspection, (2) issue parts (for supermarket), and (3) in-process cleaning (IP clean) steps from the uncoated endplates at NuVasive Manufacturing LLC (NML)

Current openFDA PMA Record#

Device: Simplify® Cervical Artificial Disc
Applicant: Nuvasive, Inc.
PMA number: P200022
Supplement: S016
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2025-06-05
Decision code: APPR
Date received: 2025-02-03
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for elimination of (1) component level inspection, (2) issue parts (for supermarket), and (3) in-process cleaning (IP clean) steps from the uncoated endplates at NuVasive Manufacturing LLC (NML)