PMA P040033S037

Device: Birmingham Hip Resurfacing (BHR) System
Applicant: Smith & Nephew, Inc.
PMA number: P040033
Supplement: S037
Product code: NXT
Decision date: 2023-02-22
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/metal, resurfacing
Approval order statement: Addition of a more time-efficient laser maker to the laser marking process for the Birmingham Hip Resurfacing System including moving the laser marking operation earlier in the manufacturing process flow.

Current openFDA PMA Record#

Device: Birmingham Hip Resurfacing (BHR) System
Applicant: Smith & Nephew, Inc.
PMA number: P040033
Supplement: S037
Product code: NXT
Generic name: Prosthesis, hip, semi-constrained, metal/metal, resurfacing
Decision date: 2023-02-22
Decision code: OK30
Date received: 2023-01-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a more time-efficient laser maker to the laser marking process for the Birmingham Hip Resurfacing System including moving the laser marking operation earlier in the manufacturing process flow.