coflex Interlaminar Stabilization

FDA Premarket Approval P110008 S013

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 revised 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 p110008.

Devicecoflex Interlaminar Stabilization
Generic NameProsthesis, Spinous Process Spacer/plate
ApplicantSurgalign Spine Technologies, Inc.
Date Received2021-01-06
Decision Date2021-03-31
PMAP110008
SupplementS013
Product CodeNQO 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address Surgalign Spine Technologies, Inc. 520 Lake Cook Road suite 315 deerfield, IL 60015

Supplemental Filings

Supplement NumberDateSupplement Type
P110008Original Filing
S013 2021-01-06 Normal 180 Day Track No User Fee
S012 2020-07-09 Special (immediate Track)
S011 2019-10-29 Normal 180 Day Track No User Fee
S010 2017-08-17 Normal 180 Day Track No User Fee
S009 2017-07-03 Normal 180 Day Track No User Fee
S008 2017-06-26 Normal 180 Day Track
S007 2016-10-18 Normal 180 Day Track No User Fee
S006 2016-09-01 Real-time Process
S005 2016-03-09 Normal 180 Day Track No User Fee
S004 2016-01-14 30-day Notice
S003 2014-02-19 Normal 180 Day Track No User Fee
S002 2012-11-26 Normal 180 Day Track No User Fee
S001 2012-11-26 Normal 180 Day Track No User Fee

NIH GUDID Devices

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