Medical Device Division · registration 220228Active

Smith & Nephew

Name: Smith & Nephew — Medical Device Division 220228
Creator: Smith & Nephew, Inc.
Keywords: Smith & Nephew, Smith & Nephew, 220228, Prostheses, Joint, Hip, Femoral Component, Medical Device Division

Hong KongProstheses, Joint, Hip, Femoral ComponentClass IIISmith & Nephew, Inc.

Verified

Official record identity

MDACS listing number: 220228
Model name: CoCr Femoral Heads 12/14 Taper Neck Length 36mm, +8 (71303608), CoCr Femoral Heads 12/14 Taper Neck Length 36mm, +4 (71303604), CoCr Femoral Heads 12/14 Taper Neck Length 36mm, -3 (71303603), CoCr Femoral Heads 12/14 Taper Neck Length 36mm, +0 (71303600), CoCr Femoral Heads 12/14 Taper Neck Length 32mm, +8 (71303208), CoCr Femoral Heads 12/14 Taper Neck Length 32mm, +4 (71303204), CoCr Femoral Heads 12/14 Taper Neck Length 32mm, -3 (71303203), CoCr Femoral Heads 12/14 Taper Neck Length 32mm, +0 (71303200), CoCr Femoral Heads 12/14 Taper Neck Length 28mm, +8 (71302808), CoCr Femoral Heads 12/14 Taper Neck Length 28mm, +4 (71302804), CoCr Femoral Heads 12/14 Taper Neck Length 28mm, -3 (71302803), CoCr Femoral Heads 12/14 Taper Neck Length 28mm, +0 (71302800), CoCr Femoral Heads 12/14 Taper Neck Length 22mm, +8 (71302208), CoCr Femoral Heads 12/14 Taper Neck Length 22mm, +4 (71302204), CoCr Femoral Heads 12/14 Taper Neck Length 22mm, +0 (71302200), Oxinium 12/14 Taper Femoral Heads 22MM +0 (71342200), Oxinium 12/14 Taper Femoral Heads 22MM +4 (71342204), Oxinium 12/14 Taper Femoral Heads 22MM +8 (71342208), Oxinium 12/14 Taper Femoral Heads 22MM +12 (71342212), Oxinium 12/14 Taper Femoral Heads 26MM +0 (71342600), Oxinium 12/14 Taper Femoral Heads 26MM +4 (71342604), Oxinium 12/14 Taper Femoral Heads 26MM +8 (71342608), Oxinium 12/14 Taper Femoral Heads 26MM +12 (71342612), Oxinium 12/14 Taper Femoral Heads 28MM +0 (71342800), Oxinium 12/14 Taper Femoral Heads 28MM -3 (71342803), Oxinium 12/14 Taper Femoral Heads 28MM +4 (71342804), Oxinium 12/14 Taper Femoral Heads 28MM +8 (71342808), Oxinium 12/14 Taper Femoral Heads 28MM +12 (71342812), Oxinium 12/14 Taper Femoral Heads 28MM +16 (71342816), Oxinium 12/14 Taper Femoral Heads 32MM +0 (71343200), Oxinium 12/14 Taper Femoral Heads 32MM -3 (71343203), Oxinium 12/14 Taper Femoral Heads 32MM +4 (71343204), Oxinium 12/14 Taper Femoral Heads 32MM +8 (71343208), Oxinium 12/14 Taper Femoral Heads 32MM +12 (71343212), Oxinium 12/14 Taper Femoral Heads 32MM +16 (71343216), Oxinium 12/14 Taper Femoral Heads 36MM +0 (71343600), Oxinium 12/14 Taper Femoral Heads 36MM -3 (71343603), Oxinium 12/14 Taper Femoral Heads 36MM +4 (71343604), Oxinium 12/14 Taper Femoral Heads 36MM +8 (71343608), Oxinium 12/14 Taper Femoral Heads 36MM +12 (71343612), Oxinium 12/14 Taper Femoral Heads 36MM +16 (71343616)
Registration date: April 29, 2026
Expiry date: August 18, 2027
Source update date: August 20, 2026
Status: Active

Classification

Risk class: Class III
Published category: Prostheses, Joint, Hip, Femoral Component

Published parties

Registrant / registration holder: Smith & Nephew Limited
Manufacturer: Smith & Nephew, Inc.

Official description

Prostheses, Joint, Hip, Femoral Component

Additional source fields

AMD nomenclature code: 16095
Traditional Chinese local responsible person: 施樂輝有限公司
Local responsible person phone: 26487700
Published manufacturer address: 1450 Brooks Road Memphis Tennessee 38116 USA
Revision number: a

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.