PMA P030022S048

Device: Reflection Ceramic Acetabular Hip System
Applicant: Smith & Nephew, Inc.
PMA number: P030022
Supplement: S048
Product code: MRA
Decision date: 2022-07-05
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Manufacturing process change by revising the hydroxyapatite (HA) powder flow limits for the Anthology stems which are approved for use in combination with the Reflection Ceramic Acetabular System.

Current openFDA PMA Record#

Device: Reflection Ceramic Acetabular Hip System
Applicant: Smith & Nephew, Inc.
PMA number: P030022
Supplement: S048
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2022-07-05
Decision code: OK30
Date received: 2022-06-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing process change by revising the hydroxyapatite (HA) powder flow limits for the Anthology stems which are approved for use in combination with the Reflection Ceramic Acetabular System.