NOVATION CERAMIC ARTICULATION HIP SYSTEM
FDA premarket approval P050039/S019 · decided 2016-07-21
Approval details
- PMA number
- P050039
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVATION CERAMIC ARTICULATION HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Exactech, Inc.
- Date received
- 2016-06-24
- Decision date
- 2016-07-21
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- Addition of an extra sealer for the packaging process. The new equipment is intended for the sealing of packages for the acetabular liner and femoral head components and mating bone screw components used with the Exactech Novation Ceramic Articulation Hip System (AHS).
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