PMA P030022S024

Device
REFLECTION CERAMIC HIP SYSTEM (RCHS)
Applicant
Smith & Nephew, Inc.
PMA number
P030022
Supplement
S024
Product code
MRA
Decision date
2013-08-06
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
APPROVAL FOR A SOFTWARE CHANGE TO ANALYZE THE STIKTITE POROUS COATINGS.

Current openFDA PMA Record#

Device
REFLECTION CERAMIC HIP SYSTEM (RCHS)
Applicant
Smith & Nephew, Inc.
PMA number
P030022
Supplement
S024
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2013-08-06
Decision code
APPR
Date received
2013-03-21
Supplement type
135 Review Track For 30-Day Notice
Approval order statement
APPROVAL FOR A SOFTWARE CHANGE TO ANALYZE THE STIKTITE POROUS COATINGS.