PMA P000013S015
- Device
- Trident Alumina Insert
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S015
- Product code
- MRA
- Decision date
- 2018-10-18
- 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
- Change in corrosion protection oil used during the vendor's proof test.
Current openFDA PMA Record#
- Device
- Trident Alumina Insert
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S015
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2018-10-18
- Decision code
- OK30
- Date received
- 2018-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in corrosion protection oil used during the vendor's proof test.