FDA.reportPublic FDA data

PMA P040033S030

Device
BIRMINGHAM HIP SYSTEM (BHR)
Applicant
Smith & Nephew, Inc.
PMA number
P040033
Supplement
S030
Product code
NXT
Decision date
2016-12-21
Classification
Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
Generic name
Prosthesis, hip, semi-constrained, metal/metal, resurfacing
Approval order statement
Approval for a manufacturing site located at Synergy Health Sterilisation UK Ltd., Brunel Close, Drayton Fields Industrial Estate, Daventry, Northamptonshire, UK NN11 8RB for the sterilization of the Birmingham Hip Resurfacing System.

Current openFDA PMA Record#

Device
BIRMINGHAM HIP SYSTEM (BHR)
Applicant
Smith & Nephew, Inc.
PMA number
P040033
Supplement
S030
Product code
NXT
Generic name
Prosthesis, hip, semi-constrained, metal/metal, resurfacing
Decision date
2016-12-21
Decision code
APPR
Date received
2016-07-29
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Synergy Health Sterilisation UK Ltd., Brunel Close, Drayton Fields Industrial Estate, Daventry, Northamptonshire, UK NN11 8RB for the sterilization of the Birmingham Hip Resurfacing System.