PMA P030022S033

Device
ANTHOLOGY FEMORAL STEMS
Applicant
Smith & Nephew, Inc.
PMA number
P030022
Supplement
S033
Product code
MRA
Decision date
2016-06-08
Classification
Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
Approval for a manufacturing site located at Orchid Detroit 23149 Commerce Drive, Farmington Hills, MI 48335.

Current openFDA PMA Record#

Device
ANTHOLOGY FEMORAL STEMS
Applicant
Smith & Nephew, Inc.
PMA number
P030022
Supplement
S033
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2016-06-08
Decision code
APPR
Date received
2015-07-27
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 Orchid Detroit 23149 Commerce Drive, Farmington Hills, MI 48335.