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.

DeviceSimplify® Cervical Artificial Disc (One-Level)
Generic NameProsthesis, Intervertebral Disc
ApplicantSimplify Medical, Inc.
Date Received2021-04-29
Decision Date2021-05-26
PMAP200022
SupplementS006
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address Simplify Medical, Inc. 685 North Pastoria Avenue sunnyvale, CA 94085

Supplemental Filings

Supplement NumberDateSupplement Type
P200022Original Filing
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 IDPMASupp
00843285101754 P200022 000
00843285100733 P200022 000
00843285100726 P200022 000
00843285100719 P200022 000
00843285100702 P200022 000
00843285100696 P200022 000
00843285100689 P200022 000
00843285100665 P200022 000
00843285100627 P200022 000
00843285100740 P200022 000
00843285100757 P200022 000
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00843285101747 P200022 000
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00843285100955 P200022 000
00843285100948 P200022 000
00843285100931 P200022 000
00843285100771 P200022 000
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00843285100047 P200022 002
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00843285100023 P200022 002
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00843285101693 P200022 002
00843285101686 P200022 002
00843285101709 P200022 002

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