FDA Registration Active 🇬🇧 United Kingdom

BIRMINGHAM HIP Dual Mobility Insert

Reg #: 3005975929 · FEI: 3005975929 · Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3

Registration Details

Registration Name
SMITH & NEPHEW ORTHOPAEDICS LTD.
Registration Number
3005975929
FEI Number
3005975929
Status
Active
Expiry Year
2025
Initial Importer
No
Address
AURORA HOUSE, SPA PARK, HARRISON WAY
City
LEAMINGTON SPA Warwickshire
Country
GB

Regulatory Submissions

510(k) Number
K171934

Owner / Operator

Firm Name
Smith & Nephew, Inc.
Operator Number
1020279
Address
2875 Railroad Street
City
Pittsburgh
State
PA
Postal Code
15222
Country
US
Correspondent
Lisa Ewing

US Agent

Business Name
SMITH & NEPHEW, INC.
Contact Name
Lisa Ewing
Address
2875 Railroad St
City
Pittsburgh
State
PA
ZIP
15222
Country
US
Phone
412 4199765

Products

Device Name Product Code
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY

Proprietary Names

BIRMINGHAM HIP Dual Mobility Insert

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility