PMA P050039S003
- Device
- EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S003
- Product code
- MRA
- Decision date
- 2009-09-30
- 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 FROM PERFORMING FLUORESCENT PENETRANT INSPECTION (FPI) AT QC LABS TO PERFORMING THE INSPECTION STEP IN-HOUSE AS WELL AS A PROCESS CHANGE AT CERAMTEC.
Current openFDA PMA Record#
- Device
- EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S003
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2009-09-30
- Decision code
- OK30
- Date received
- 2009-08-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FROM PERFORMING FLUORESCENT PENETRANT INSPECTION (FPI) AT QC LABS TO PERFORMING THE INSPECTION STEP IN-HOUSE AS WELL AS A PROCESS CHANGE AT CERAMTEC.