Mobi-C Cervical Disc Prosthesis (one-level indications)

Prosthesis, Intervertebral Disc

FDA Premarket Approval P110002 S022

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

For a new manufacturing site to be used for kitting and shipping of mobi-c as well as reconditioning and servicing of instruments from the field for reuse

DeviceMobi-C Cervical Disc Prosthesis (one-level indications)
Classification NameProsthesis, Intervertebral Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantLDR Spine USA
Date Received2019-09-04
Decision Date2019-11-13
PMAP110002
SupplementS022
Product CodeMJO
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address LDR Spine USA 13785 Research Boulevard suite 200 austin, TX 78750

Supplemental Filings

Supplement NumberDateSupplement Type
P110002Original Filing
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
S017
S016 2016-11-01 Normal 180 Day Track No User Fee
S015 2016-09-30 Normal 180 Day Track No User Fee
S014
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 Normal 180 Day Track No User Fee
S001 2013-09-12 Normal 180 Day Track No User Fee

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