Prosthesis, Intervertebral Disc

FDA Premarket Approval P110009

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the mobi-c® cervical disc prosthesis. This device is indicated in skeletally mature patients for reconstruction of the disc from c3-c7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (ct, mri, x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. The mobi-c® cervical disc prosthesis is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the mobic® cervical disc prosthesis.

Classification NameProsthesis, Intervertebral Disc
Generic NameProsthesis, Intervertebral Disc
Date Received2011-03-11
Decision Date2013-08-23
Notice Date2013-09-10
Product CodeMJO
Docket Number13M-1095
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address LDR SPINE USA INC. 13785 Research Boulevard suite 200 austin, TX 78750
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

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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