PMA P040033S038

Device: Birmingham Hip Resurfacing (BHR) System
Applicant: Smith & Nephew, Inc.
PMA number: P040033
Supplement: S038
Product code: NXT
Decision date: 2024-01-19
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/metal, resurfacing
Approval order statement: a change to the Catalog Item (CI) reference codes (i.e., US market only) for the BIRMINGHAM HIP RESURFACING SYSTEM femoral head and acetabular cup implants

Current openFDA PMA Record#

Device: Birmingham Hip Resurfacing (BHR) System
Applicant: Smith & Nephew, Inc.
PMA number: P040033
Supplement: S038
Product code: NXT
Generic name: Prosthesis, hip, semi-constrained, metal/metal, resurfacing
Decision date: 2024-01-19
Decision code: APPR
Date received: 2023-12-20
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: a change to the Catalog Item (CI) reference codes (i.e., US market only) for the BIRMINGHAM HIP RESURFACING SYSTEM femoral head and acetabular cup implants