PMA P050009S001
- Device
- C2A-TAPER ACETABULAR SYSTEM
- Applicant
- Biomet, Inc.
- PMA number
- P050009
- Supplement
- S001
- Product code
- MRA
- Decision date
- 2006-02-01
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- MANUFACTURING PROCESS CHANGES BY CERAMTEC, INC. FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS.
Current openFDA PMA Record#
- Device
- C2A-TAPER ACETABULAR SYSTEM
- Applicant
- Biomet, Inc.
- PMA number
- P050009
- Supplement
- S001
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2006-02-01
- Decision code
- OK30
- Date received
- 2006-01-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING PROCESS CHANGES BY CERAMTEC, INC. FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS.