PMA P050039S019
- Device
- NOVATION CERAMIC ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S019
- Product code
- MRA
- Decision date
- 2016-07-21
- 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
- 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).
Current openFDA PMA Record#
- Device
- NOVATION CERAMIC ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S019
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2016-07-21
- Decision code
- OK30
- Date received
- 2016-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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).