Simplify Cervical Artificial Disc

FDA Premarket Approval P200022 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for changes to the simplify clip, a packaging component of the simplify disc

• Device: Simplify Cervical Artificial Disc
• Generic Name: Prosthesis, Intervertebral Disc
• Applicant: Simplify Medical, Inc.
• Date Received: 2021-01-12
• Decision Date: 2021-02-10
• PMA: P200022
• Supplement: S004
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Simplify Medical, Inc. 685 North Pastoria Avenue sunnyvale, CA 94085

Supplemental Filings

Supplement Number	Date	Supplement Type
P200022		Original Filing
S008	2022-01-14	30-day Notice
S007	2021-06-25	30-day Notice
S006	2021-04-29	Normal 180 Day Track No User Fee
S005	2021-04-28	Normal 180 Day Track No User Fee
S004	2021-01-12	30-day Notice
S003
S002	2020-10-07	Normal 180 Day Track No User Fee
S001

NIH GUDID Devices

Device ID	PMA	Supp
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