PMA P050016S001

Device
CORMET HIP RESURFACING SYSTEM
Applicant
Corin USA
PMA number
P050016
Supplement
S001
Product code
NXT
Decision date
2007-10-18
Classification
Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
Generic name
Prosthesis, hip, semi-constrained, metal/metal, resurfacing
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY.

Current openFDA PMA Record#

Device
CORMET HIP RESURFACING SYSTEM
Applicant
Corin USA
PMA number
P050016
Supplement
S001
Product code
NXT
Generic name
Prosthesis, hip, semi-constrained, metal/metal, resurfacing
Decision date
2007-10-18
Decision code
APPR
Date received
2007-07-16
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY.