PMA P030022S037

Device: REFLECTION CERAMIC Acetabular Hip SYSTEM (RCHS)
Applicant: Smith & Nephew, Inc.
PMA number: P030022
Supplement: S037
Product code: MRA
Decision date: 2016-10-04
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Approval for packaging change to the SYNERGY, SPECTRON, and ANTHOLOGY hip stems used as part of the subject PMA device; REFLECTION Ceramic Hip System.

Current openFDA PMA Record#

Device: REFLECTION CERAMIC Acetabular Hip SYSTEM (RCHS)
Applicant: Smith & Nephew, Inc.
PMA number: P030022
Supplement: S037
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2016-10-04
Decision code: APPR
Date received: 2016-07-07
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for packaging change to the SYNERGY, SPECTRON, and ANTHOLOGY hip stems used as part of the subject PMA device; REFLECTION Ceramic Hip System.