prodisc L

FDA Premarket Approval P050010 S023

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

A change to eliminate redundant quality control method regarding endplate coating thickness

Deviceprodisc L
Generic NameProsthesis, Intervertebral Disc
ApplicantCentinel Spine, LLC
Date Received2021-03-01
Decision Date2021-03-15
PMAP050010
SupplementS023
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Centinel Spine, LLC 900 Airport Road, Suite 3b west Chester, PA 19380

Supplemental Filings

Supplement NumberDateSupplement Type
P050010Original Filing
S023 2021-03-01 30-day Notice
S022 2019-09-09 Real-time Process
S021
S020
S019 2017-10-18 30-day Notice
S018
S017 2016-01-15 30-day Notice
S016 2014-04-03 135 Review Track For 30-day Notice
S015
S014 2012-12-07 Normal 180 Day Track
S013 2012-11-08 Normal 180 Day Track No User Fee
S012 2011-04-26 Real-time Process
S011 2011-01-28 135 Review Track For 30-day Notice
S010 2010-09-29 135 Review Track For 30-day Notice
S009 2010-09-15 135 Review Track For 30-day Notice
S008 2010-08-02 Real-time Process
S007 2010-05-19 Normal 180 Day Track No User Fee
S006 2010-04-26 30-day Notice
S005 2010-04-26 30-day Notice
S004
S003 2008-07-28 30-day Notice
S002 2008-05-29 135 Review Track For 30-day Notice
S001 2007-12-26 Real-time Process

NIH GUDID Devices

Device IDPMASupp
10705034700182 P050010 000
H981PDLMPT14S0T P050010 000
H981PDLMPT12S0R P050010 000
H981PDLMPT10S0P P050010 000
H981PDLMIP00S0D P050010 000
H981PDLLSP11S0O P050010 000
H981PDLLSP06S0S P050010 000
H981PDLLPT14S0S P050010 000
H981PDLLPT12S0Q P050010 000
H981PDLLPT10S0O P050010 000
H981PDLMSP06S0T P050010 000
H981PDLMSP11S0P P050010 000
10705034700045 P050010 000
10705034700175 P050010 000
10705034700151 P050010 000
10705034700144 P050010 000
10705034700137 P050010 000
10705034700106 P050010 000
10705034700090 P050010 000
10705034700083 P050010 000
10705034700069 P050010 000
10705034700052 P050010 000
H981PDLLIP00S0C P050010 000

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