PMA P070026S080

Device: CERAMAX Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S080
Product code: MRA
Decision date: 2021-04-30
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Additional inspection equipment (i.e., Zeiss Contura, DE1093 coordinate measurement machine/CMM) as an additional inspection asset to be used with the current measurement equipment to inspect critical features of the Summit Hip Stem components.

Current openFDA PMA Record#

Device: CERAMAX Ceramic Total Hip System
Applicant: DePuy Orthopaedics, Inc.
PMA number: P070026
Supplement: S080
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2021-04-30
Decision code: OK30
Date received: 2021-04-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Additional inspection equipment (i.e., Zeiss Contura, DE1093 coordinate measurement machine/CMM) as an additional inspection asset to be used with the current measurement equipment to inspect critical features of the Summit Hip Stem components.