PMA N980003
- Device
- KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
- Applicant
- Djo Surgical
- Product code
- MRA
- Decision date
- 2009-02-13
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- APPROVAL FOR THE USE OF POLYETHYLENE REPLACEMENT ACETABULAR LINERS.
Current openFDA PMA Record#
- Device
- KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
- Applicant
- Djo Surgical
- PMA number
- N980003
- Supplement
- S007
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2009-02-13
- Decision code
- APPR
- Date received
- 2008-05-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF POLYETHYLENE REPLACEMENT ACETABULAR LINERS.