SECURE-C CERVICAL ARTIFICIAL DISC

FDA Premarket Approval P100003 S002

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

Approval for additional device-specific instrumentation associated with the secure®-c cervical artificial disc.

DeviceSECURE-C CERVICAL ARTIFICIAL DISC
Generic NameProsthesis, Intervertebral Disc
ApplicantGLOBUS MEDICAL INC.
Date Received2013-06-06
Decision Date2013-09-06
PMAP100003
SupplementS002
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address GLOBUS MEDICAL INC. 2560 General Armistead Ave. audubon, PA 19403

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

Device IDPMASupp
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00889095154948 P100003 000
00889095154931 P100003 000
00889095154924 P100003 000
00889095154917 P100003 000
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00889095154894 P100003 000
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00889095154849 P100003 000
00889095154832 P100003 000
00889095154825 P100003 000
00889095154818 P100003 000
00889095154801 P100003 000
00889095154955 P100003 000
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00889095179095 P100003 000
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00889095179057 P100003 000
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00889095179187 P100003 005
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00889095179088 P100003 005
00889095179071 P100003 005
00889095179200 P100003 005

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