EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
FDA premarket approval P050039/S003 · decided 2009-09-30
Approval details
- PMA number
- P050039
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Exactech, Inc.
- Date received
- 2009-08-19
- Decision date
- 2009-09-30
- Days to decision
- 42 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Gainesville, FL
- 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.
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