PMA P000013S013

Device
TRIDENT CERAMIC INSERT
Applicant
Howmedica Osteonics Corp.
PMA number
P000013
Supplement
S013
Product code
MRA
Decision date
2016-03-04
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
Upgrades to the systems at a vendor.

Current openFDA PMA Record#

Device
TRIDENT CERAMIC INSERT
Applicant
Howmedica Osteonics Corp.
PMA number
P000013
Supplement
S013
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2016-03-04
Decision code
OK30
Date received
2016-02-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Upgrades to the systems at a vendor.