NUVASIVE'S PCM CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Premarket Approval P100012 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 of the post-approval study protocol.

• Device: NUVASIVE'S PCM CERVICAL DISC
• Classification Name: Prosthesis, Intervertebral Disc
• Generic Name: Prosthesis, Intervertebral Disc
• Applicant: NUVASIVE, INC.
• Date Received: 2012-11-19
• Decision Date: 2013-02-06
• PMA: P100012
• Supplement: S001
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - Osb
• Expedited Review: No
• Combination Product: No
• Applicant Address: NUVASIVE, INC. 7475 Lusk Blvd san Diego, CA 92121

Supplemental Filings

Supplement Number	Date	Supplement Type
P100012		Original Filing
S008	2018-05-03	Normal 180 Day Track No User Fee
S007
S006	2014-09-26	Normal 180 Day Track
S005	2013-12-18	Real-time Process
S004	2013-03-04	Normal 180 Day Track No User Fee
S003	2012-11-19	Normal 180 Day Track No User Fee
S002	2013-01-22	Special (immediate Track)
S001	2012-11-19	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
00887517403438	P100012	000
00887517075970	P100012	000
00887517075987	P100012	000
00887517075994	P100012	000
00887517076502	P100012	000
00887517077349	P100012	000
00887517078537	P100012	000
00887517078544	P100012	000
00887517081124	P100012	000
00887517081131	P100012	000
00887517081148	P100012	000
00887517081155	P100012	000
00887517075963	P100012	000
00887517075956	P100012	000
00887517075949	P100012	000
00887517403445	P100012	000
00887517403452	P100012	000
00887517403469	P100012	000
00887517403476	P100012	000
00887517403483	P100012	000
00887517605184	P100012	000
00887517605191	P100012	000
00887517605207	P100012	000
00887517605214	P100012	000
00887517601148	P100012	000
00887517601155	P100012	000
00887517081162	P100012	000
00887517081179	P100012	000
00887517083555	P100012	000
00887517083562	P100012	000
00887517083579	P100012	000
00887517083593	P100012	000
00887517084002	P100012	000
00887517084019	P100012	000
00887517084026	P100012	000
00887517084033	P100012	000
00887517084040	P100012	000
00887517084057	P100012	000
00887517084064	P100012	000
00887517083166	P100012	000
00887517083159	P100012	000
00887517083142	P100012	000
00887517081186	P100012	000
00887517081193	P100012	000
00887517081605	P100012	000
00887517082565	P100012	000
00887517082572	P100012	000
00887517082589	P100012	000
00887517082596	P100012	000
00887517083104	P100012	000
00887517083111	P100012	000
00887517083128	P100012	000
00887517083135	P100012	000
00887517084071	P100012	000