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

DeviceSimplify Cervical Artificial Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantSimplify Medical, Inc.
Date Received2021-01-12
Decision Date2021-02-10
PMAP200022
SupplementS004
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Simplify Medical, Inc. 685 North Pastoria Avenue sunnyvale, CA 94085

Supplemental Filings

Supplement NumberDateSupplement Type
P200022Original 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

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