Simplify® Cervical Artificial Disc (2 Level)

FDA Premarket Approval P200022 S005

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 the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p200022/s003.

• Device: Simplify® Cervical Artificial Disc (2 Level)
• Generic Name: Prosthesis, Intervertebral Disc
• Applicant: Simplify Medical, Inc.
• Date Received: 2021-04-28
• Decision Date: 2021-05-28
• PMA: P200022
• Supplement: S005
• 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
00843285102034	P200022	000
00843285101891	P200022	000
00843285101884	P200022	000
00843285101877	P200022	000
00843285101778	P200022	000
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00843285101907	P200022	000
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00843285102027	P200022	000
00843285102010	P200022	000
00843285102003	P200022	000
00843285101990	P200022	000
00843285101983	P200022	000
00843285101976	P200022	000
00843285101969	P200022	000
00843285101952	P200022	000
00843285101938	P200022	000
00843285101020	P200022	000
00843285101013	P200022	000
00195377105479	P200022	000
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00195377105455	P200022	000
00195377105448	P200022	000
00195377105431	P200022	000
00195377105424	P200022	000
00195377105417	P200022	000
00195377105400	P200022	000
00195377160256	P200022	000
00195377105486	P200022	000
00195377105493	P200022	000
00843285101006	P200022	000
00843285100993	P200022	000
00843285100924	P200022	000
00843285100894	P200022	000
00195377105547	P200022	000
00195377105530	P200022	000
00195377105523	P200022	000
00195377105516	P200022	000
00195377105509	P200022	000
00195377166517	P200022	000
00843285102041	P200022	000
00843285101754	P200022	000
00843285100627	P200022	000
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00843285100696	P200022	000
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00843285102188	P200022	000
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00843285100078	P200022	002