Simplify® Cervical Artificial Disc (One-Level)

FDA Premarket Approval P200022 S006

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 of changes to the previously approved pas protocol (p200022/s002) for the post-approval study (pas) entitled extended follow-up of ide subjects treated with the simplify® cervical artificial disc.

• Device: Simplify® Cervical Artificial Disc (One-Level)
• Generic Name: Prosthesis, Intervertebral Disc
• Applicant: Simplify Medical, Inc.
• Date Received: 2021-04-29
• Decision Date: 2021-05-26
• PMA: P200022
• Supplement: S006
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• 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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00195377166517	P200022	000
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