Smith & Nephew LEGION CONES - HSA Registration DE0504284

Access comprehensive regulatory information for Smith & Nephew LEGION CONES in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504284 and owned by Smith & Nephew, Inc.. The device was registered on March 26, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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HSA Official Data

CLASS C

DE0504284

Smith & Nephew LEGION CONES

HSA Registration Number: DE0504284

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Product Description

It is intended to be used with LEGION Revision & LEGION Hinge knee systems, with/without cement: 1. Rheumatoid arthritis. 2. Post traumatic arthritis, osteoarthritis, or degenerative arthritis 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 5. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.

Device Classification

Device Class

CLASS C

Medical Speciality Area

Orthopaedics

Registration Information

Registration Number

DE0504284

Registration Date

March 26, 2020

Change Notification Approval Date

November 05, 2024

Retention Due Date

March 25, 2026

Product Owner

Name

Smith & Nephew, Inc.

Short Name

Smith & Nephew, Inc

Address

1450 Brooks Road, Memphis, Tennessee, 38116, UNITED STATES

Registrant

Name

SMITH & NEPHEW PTE. LIMITED

Address

29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565

Importer

Name

SMITH & NEPHEW ASIA PACIFIC PTE. LIMITED SMITH & NEPHEW PTE. LIMITED

Address

29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565

Model Information

Model Name(s)

LEGION TIBIAL CONE TRIAL ID 18 SHORT LEGION TIBIAL CONE TRIAL ID 20 SHORT LEGION TIBIAL CONE TRIAL ID 22 SHORT LEGION TIBIAL CONE TRIAL ID 24 SHORT LEGION TIBIAL CONE TRIAL ID 26 SHORT LEGION TIBIAL CONE TRIAL ID 28 SHORT LEGION TIBIAL CONE TRIAL ID 30 SHORT LEGION TIBIAL CONE TRIAL ID 18 LONG LEGION TIBIAL CONE TRIAL ID 20 LONG LEGION TIBIAL CONE TRIAL ID 22 LONG LEGION TIBIAL CONE TRIAL ID 24 LONG LEGION TIBIAL CONE TRIAL ID 26 LONG LEGION TIBIAL CONE TRIAL ID 28 LONG LEGION TIBIAL CONE TRIAL ID 30 LONG LEGION FEM CONE TRIAL ID 18MM LEFT LEGION FEM CONE TRIAL ID 20MM LEFT LEGION FEM CONE TRIAL ID 22MM LEFT LEGION FEM CONE TRIAL ID 24MM LEFT LEGION FEM CONE TRIAL ID 26MM LEFT LEGION FEM CONE TRIAL ID 28MM LEFT LEGION FEM CONE TRIAL ID 30MM LEFT LEGION FEM CONE TRIAL ID 18MM RIGHT LEGION FEM CONE TRIAL ID 20MM RIGHT LEGION FEM CONE TRIAL ID 22MM RIGHT LEGION FEM CONE TRIAL ID 24MM RIGHT LEGION FEM CONE TRIAL ID 26MM RIGHT LEGION FEM CONE TRIAL ID 28MM RIGHT LEGION FEM CONE TRIAL ID 30MM RIGHT LEGION FEMORAL CONE REAMER 18MM LEGION TIB CONE BROACH ID 18 SHORT LEGION TIB CONE BROACH ID 20 SHORT LEGION TIB CONE BROACH ID 22 SHORT LEGION TIB CONE BROACH ID 24 SHORT LEGION TIB CONE BROACH ID 26 SHORT LEGION TIB CONE BROACH ID 28 SHORT LEGION TIB CONE BROACH ID 30 SHORT LEGION TIB CONE BROACH ID 18 LONG LEGION TIB CONE BROACH ID 20 LONG LEGION TIB CONE BROACH ID 22 LONG LEGION TIB CONE BROACH ID 24 LONG LEGION TIB CONE BROACH ID 26 LONG LEGION TIB CONE BROACH ID 28 LONG LEGION TIB CONE BROACH ID 30 LONG LEGION FEM CONE BROACH ID 18 LEFT LEGION FEM CONE BROACH ID 20 LEFT LEGION FEM CONE BROACH ID 22 LEFT LEGION FEM CONE BROACH ID 24 LEFT LEGION FEM CONE BROACH ID 26 LEFT LEGION FEM CONE BROACH ID 28 LEFT LEGION FEM CONE BROACH ID 30 LEFT LEGION FEM CONE BROACH ID 18 RIGHT LEGION FEM CONE BROACH ID 20 RIGHT LEGION FEM CONE BROACH ID 22 RIGHT LEGION FEM CONE BROACH ID 24 RIGHT LEGION FEM CONE BROACH ID 26 RIGHT LEGION FEM CONE BROACH ID 28 RIGHT LEGION FEM CONE BROACH ID 30 RIGHT LEGION TIB CONE IMPACTOR HEAD ID 18MM LEGION TIB CONE IMPACTOR HEAD ID 20MM LEGION TIB CONE IMPACTOR HEAD ID 22MM LEGION TIB CONE IMPACTOR HEAD ID 24MM LEGION TIB CONE IMPACTOR HEAD ID 26MM LEGION TIB CONE IMPACTOR HEAD ID 28MM LEGION TIB CONE IMPACTOR HEAD ID 30MM LEGION FEM CONE IMPACTOR HEAD ID18MM LEGION FEM CONE IMPACTOR HEAD ID 20MM LEGION FEM CONE IMPACTOR HEAD ID 22MM LEGION FEM CONE IMPACTOR HEAD ID 24-30MM LEGION TIBIAL CONE REMOVAL TOOL LEGION TIBIAL CONE REAMER 18MM LEGION CONE IMPACTOR HANDLE LGN TIB CONE IMPCTR HNDL 2MM OFFST SLV LGN TIB CONE IMPCTR HNDL 4MM OFFST SLV LGN TIB CONE IMPCTR HNDL 6MM OFFST SLV LGN CONE IMPCTR HNDL NEUTRAL SLV LGN TIB CONE IMPCTR HNDL 2MM VARIB SLV LGN TIB CONE IMPCTR HNDL 4MM VARIB SLV LGN TIB CONE IMPCTR HNDL 6MM VARIB SLV Legion Tibial Metaphyseal Cone Tray Legion Femoral Metaphyseal Cone Tray Legion Cone Broach Handle Tray LEGION Tibial Cone ID 18 SHORT LEGION Tibial Cone ID 20 SHORT LEGION Tibial Cone ID 22 SHORT LEGION Tibial Cone ID 24 SHORT LEGION Tibial Cone ID 26 SHORT LEGION Tibial Cone ID 28 SHORT LEGION Tibial Cone ID 30 SHORT LEGION Tibial Cone ID 18 LONG LEGION Tibial Cone ID 20 LONG LEGION Tibial Cone ID 22 LONG LEGION Tibial Cone ID 24 LONG LEGION Tibial Cone ID 26 LONG LEGION Tibial Cone ID 28 LONG LEGION Tibial Cone ID 30 LONG LEGION Femoral Cone ID 18 LEFT LEGION Femoral Cone ID 20 LEFT LEGION Femoral Cone ID 22 LEFT LEGION Femoral Cone ID 24 LEFT LEGION Femoral Cone ID 26 LEFT LEGION Femoral Cone ID 28 LEFT LEGION Femoral Cone ID 30 LEFT LEGION Femoral Cone ID 18 RIGHT LEGION Femoral Cone ID 20 RIGHT LEGION Femoral Cone ID 22 RIGHT LEGION Femoral Cone ID 24 RIGHT LEGION Femoral Cone ID 26 RIGHT LEGION Femoral Cone ID 28 RIGHT LEGION Femoral Cone ID 30 RIGHT

Model Identifier(s)

71431841 71431842 71431843 71431844 71431845 71431846 71431847 71431848 71431849 71431851 71431852 71431853 71431854 71431855 71431893 71431894 71431895 71431896 71431897 71431898 71431899 71431901 71431902 71431903 71431904 71431905 71431906 71431907 71441891 71441901 71441902 71441903 71441904 71441905 71441906 71441907 71441908 71441909 71441911 71441912 71441913 71441914 71441915 71441953 71441954 71441955 71441956 71441957 71441958 71441959 71441961 71441962 71441963 71441964 71441965 71441966 71441967 71441968 71441969 71441971 71441972 71441973 71441974 71441975 71441976 71441977 71441978 71441979 71441989 71441991 71442011 71442012 71442013 71442014 71442018 71442019 71442021 71442022 71442031 71442032 71442034 71935386 71935387 71935388 71935389 71935390 71935391 71935392 71935393 71935394 71935395 71935396 71935397 71935398 71935399 71935400 71935401 71935402 71935403 71935404 71935405 71935406 71935407 71935408 71935409 71935410 71935411 71935412 71935413