PMA P100012S006

Device
NU VASIVE PCM CERVICAL DISC SYSTEM
Applicant
Nuvasive, Inc.
PMA number
P100012
Supplement
S006
Product code
MJO
Decision date
2014-12-19
Classification
Prosthesis, Intervertebral Disc
Generic name
Prosthesis, intervertebral disc
Approval order statement
APPROVAL FOR A LOCKING PLATE DESIGN MODIFICATION, ADDITIONAL DEVICE SIZES AND MAGNETIC RESONANCE (MR) CONDITIONAL LABELING.

Current openFDA PMA Record#

Device
NU VASIVE PCM CERVICAL DISC SYSTEM
Applicant
Nuvasive, Inc.
PMA number
P100012
Supplement
S006
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2014-12-19
Decision code
APPR
Date received
2014-09-26
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A LOCKING PLATE DESIGN MODIFICATION, ADDITIONAL DEVICE SIZES AND MAGNETIC RESONANCE (MR) CONDITIONAL LABELING.