PMA P070026S046
- Device
- CERAMAX® Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S046
- Product code
- MRA
- Decision date
- 2017-11-08
- 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
- Approval for the addition of a Ceramic Liner Inserter Instrument and corresponding labeling changes to the surgical technique.
Current openFDA PMA Record#
- Device
- CERAMAX® Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S046
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2017-11-08
- Decision code
- APPR
- Date received
- 2017-02-16
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of a Ceramic Liner Inserter Instrument and corresponding labeling changes to the surgical technique.