MOBI-C Cervical Disc Prosthesis

Prosthesis, Intervertebral Disc

FDA Premarket Approval P110009 S019

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

Manufacturing changes that include the addition of a new plasma spray coating supplier and raw titanium material supplier

DeviceMOBI-C Cervical Disc Prosthesis
Classification NameProsthesis, Intervertebral Disc
Generic NameProsthesis, Intervertebral Disc
Date Received2017-05-05
Decision Date2017-06-02
Product CodeMJO
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address LDR SPINE USA INC. 13785 Research Boulevard suite 200 austin, TX 78750

Supplemental Filings

Supplement NumberDateSupplement Type
P110009Original Filing
S034 2022-11-08 30-day Notice
S032 2022-01-21 135 Review Track For 30-day Notice
S031 2021-10-05 30-day Notice
S030 2021-04-08 30-day Notice
S029 2021-01-19 30-day Notice
S026 2020-11-23 30-day Notice
S024 2020-03-17 30-day Notice
S023 2020-01-21 30-day Notice
S022 2019-09-04 Normal 180 Day Track No User Fee
S021 2018-04-17 30-day Notice
S020 2018-01-05 Normal 180 Day Track No User Fee
S019 2017-05-05 30-day Notice
S018 2017-04-26 30-day Notice
S016 2016-11-01 Normal 180 Day Track No User Fee
S015 2016-09-30 Normal 180 Day Track No User Fee
S013 2015-12-31 30-day Notice
S012 2015-06-05 Special (immediate Track)
S011 2015-04-20 Normal 180 Day Track
S010 2015-04-06 Normal 180 Day Track No User Fee
S009 2014-12-08 Real-time Process
S008 2014-12-08 30-day Notice
S007 2014-06-27 30-day Notice
S006 2014-04-04 30-day Notice
S005 2014-03-28 Normal 180 Day Track No User Fee
S004 2014-01-24 30-day Notice
S003 2013-11-18 30-day Notice
S002 2013-09-12 Special (immediate Track)
S001 2013-09-12 Normal 180 Day Track No User Fee

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