Simplify Cervical Artificial Disc

FDA Premarket Approval P200022 S002

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.

DeviceSimplify Cervical Artificial Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantSimplify Medical, Inc.
Date Received2020-10-07
Decision Date2020-11-05
PMAP200022
SupplementS002
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address Simplify Medical, Inc. 685 North Pastoria Avenue sunnyvale, CA 94085

Supplemental Filings

Supplement NumberDateSupplement Type
P200022Original Filing
S002 2020-10-07 Normal 180 Day Track No User Fee
S001

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