PMA P030022S032

Device
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
Applicant
Smith & Nephew, Inc.
PMA number
P030022
Supplement
S032
Product code
MRA
Decision date
2015-09-25
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 AN INNER LID PACKAGING CHANGE TO BIOLOX FORTE CERAMIC HEADS.

Current openFDA PMA Record#

Device
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
Applicant
Smith & Nephew, Inc.
PMA number
P030022
Supplement
S032
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2015-09-25
Decision code
APPR
Date received
2015-07-27
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR AN INNER LID PACKAGING CHANGE TO BIOLOX FORTE CERAMIC HEADS.