SECURE-C ARTIFICIAL CERVICAL DISC

FDA Premarket Approval P100003

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 secure-c artificial cervical disc. This device is indicated in skeletally mature patients for reconstruction ofthe disc at one level from c3-c7 following single- level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-levelabnormality localized to 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 as compared to adjacent levels. The secure-c cervical artificial disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the secure-c cervical artificial disc.

DeviceSECURE-C ARTIFICIAL CERVICAL DISC
Generic NameProsthesis, Intervertebral Disc
ApplicantGLOBUS MEDICAL INC.
Date Received2010-01-29
Decision Date2012-09-28
Notice Date2012-10-02
PMAP100003
SupplementS
Product CodeMJO 
Docket Number12M-1039
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address GLOBUS MEDICAL INC. 2560 General Armistead Ave. audubon, PA 19403
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
P100003Original Filing
S007 2016-12-30 Normal 180 Day Track No User Fee
S006 2015-07-01 Real-time Process
S005 2013-07-05 Normal 180 Day Track
S004
S003 2013-06-21 Normal 180 Day Track No User Fee
S002 2013-06-06 Real-time Process
S001 2013-02-13 Special (immediate Track)

NIH GUDID Devices

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