SECURE -C CERVICAL ARTIFICIAL DISC

FDA Premarket Approval P100003 S001

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 a minor modification of the narrow implant holder (part #614. 805).

DeviceSECURE -C CERVICAL ARTIFICIAL DISC
Generic NameProsthesis, Intervertebral Disc
ApplicantGLOBUS MEDICAL INC.
Date Received2013-02-13
Decision Date2013-03-15
PMAP100003
SupplementS001
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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
00889095154795 P100003 000
00889095154948 P100003 000
00889095154931 P100003 000
00889095154924 P100003 000
00889095154917 P100003 000
00889095154900 P100003 000
00889095154894 P100003 000
00889095154887 P100003 000
00889095154870 P100003 000
00889095154863 P100003 000
00889095154856 P100003 000
00889095154849 P100003 000
00889095154832 P100003 000
00889095154825 P100003 000
00889095154818 P100003 000
00889095154801 P100003 000
00889095154955 P100003 000
00889095154962 P100003 000
00889095179132 P100003 000
00889095179101 P100003 000
00889095179095 P100003 000
00889095179064 P100003 000
00889095179057 P100003 000
00889095179149 P100003 000
00889095179187 P100003 005
00889095179194 P100003 005
00889095179170 P100003 005
00889095179163 P100003 005
00889095179156 P100003 005
00889095179125 P100003 005
00889095179118 P100003 005
00889095179088 P100003 005
00889095179071 P100003 005
00889095179200 P100003 005

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