Medical Device Division · registration 220367Active

Smith & Nephew

Name: Smith & Nephew — Medical Device Division 220367
Creator: Smith & Nephew, Inc.
Keywords: Smith & Nephew, Smith & Nephew, 220367, Prostheses, Joint, Hip, Femoral Component, Medical Device Division

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

Verified

Official record identity

MDACS listing number: 220367
Model name: OR3O Dual Mobility System (71353301, 71353302, 71353303, 71353304, 71353305, 71353306, 71353307, 71353308, 71353309, 71353311, 71353313, 71353314, 71353316, 71353318, 71353319, 71353321, 71353322, 71353323, 71353324, 71353348, 71353352, 71353354, 71353355, 71362806, 71358201, 71358202, 71358203, 71358204, 71358205, 71358206, 71358207, 71358208, 71358209, 71358211, 71358213, 71358214, 71358216, 71358218, 71358219, 71358221, 71358222, 71358223, 71358224, 71358251, 71358252, 71358253, 71358254, 71358215, 71358217)
Registration date: March 26, 2026
Expiry date: November 03, 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.