FDA.reportPublic FDA data

PMA P070026S083

Device
CERAMAX Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S083
Product code
MRA
Decision date
2021-07-20
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
Addition of an alternate supplier for one of the raw materials used for manufacturing the ceramic components of the CERAMAX® Ceramic Total Hip System.

Current openFDA PMA Record#

Device
CERAMAX Ceramic Total Hip System
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S083
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2021-07-20
Decision code
OK30
Date received
2021-06-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate supplier for one of the raw materials used for manufacturing the ceramic components of the CERAMAX® Ceramic Total Hip System.