PMA P200022S017

Device: Simplify® Cervical Artificial Disc
Applicant: Nuvasive, Inc.
PMA number: P200022
Supplement: S017
Product code: MJO
Decision date: 2025-05-29
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: a change to add PAC, a previously qualified supplier for DOT America, as an additional source for the same 45 Mesh Titanium powder for titanium spray coating of the Simplify Endplates

Current openFDA PMA Record#

Device: Simplify® Cervical Artificial Disc
Applicant: Nuvasive, Inc.
PMA number: P200022
Supplement: S017
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2025-05-29
Decision code: OK30
Date received: 2025-05-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to add PAC, a previously qualified supplier for DOT America, as an additional source for the same 45 Mesh Titanium powder for titanium spray coating of the Simplify Endplates