PMA P030022S022

Device
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
Applicant
Smith & Nephew, Inc.
PMA number
P030022
Supplement
S022
Product code
MRA
Decision date
2012-09-06
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
ADDITION OF AN ALTERNATE VENDOR FOR THE ANTHOLOGY HIP STEM POROUS COATING PROCESS.

Current openFDA PMA Record#

Device
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
Applicant
Smith & Nephew, Inc.
PMA number
P030022
Supplement
S022
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2012-09-06
Decision code
OK30
Date received
2012-08-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AN ALTERNATE VENDOR FOR THE ANTHOLOGY HIP STEM POROUS COATING PROCESS.