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Smith & Nephew R3 Acetabular Shells - HSA Registration DE0506346

Access comprehensive regulatory information for Smith & Nephew R3 Acetabular Shells in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506346 and owned by Smith & Nephew, Inc.. The device was registered on November 03, 2021.

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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CLASS C
DE0506346
Smith & Nephew R3 Acetabular Shells
HSA Registration Number: DE0506346
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Product Description

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; facture-dislocation of the hip; and correction of deformity.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0506346
Registration Date
November 03, 2021
Change Notification Approval Date
December 14, 2023
Retention Due Date
November 02, 2025
Product Owner
Short Name
Smith & Nephew, Inc
Address
1450 Brooks Road, Memphis, Tennessee, 38116, UNITED STATES
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Importer
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Model Information
Model Name(s)
R3 Three Hole Hemispherical Shell 40mm R3 Three Hole Hemispherical Shell 42mm R3 Three Hole Hemispherical Shell 44mm R3 Three Hole Hemispherical Shell 46mm R3 Three Hole Hemispherical Shell 48mm R3 Three Hole Hemispherical Shell 50mm R3 Three Hole Hemispherical Shell 52mm R3 Three Hole Hemispherical Shell 54mm R3 Three Hole Hemispherical Shell 56mm R3 Three Hole Hemispherical Shell 58mm R3 Three Hole Hemispherical Shell 60mm R3 Three Hole Hemispherical Shell 62mm R3 Three Hole Hemispherical Shell 64mm R3 Multi-Hole Hemispherical Shell 46mm R3 Multi-Hole Hemispherical Shell 48mm R3 Multi-Hole Hemispherical Shell 50mm R3 Multi-Hole Hemispherical Shell 52mm R3 Multi-Hole Hemispherical Shell 54mm R3 Multi-Hole Hemispherical Shell 56mm R3 Multi-Hole Hemispherical Shell 58mm R3 Multi-Hole Hemispherical Shell 60mm R3 Multi-Hole Hemispherical Shell 62mm R3 Multi-Hole Hemispherical Shell 64mm R3 Multi-Hole Hemispherical Shell 66mm R3 Multi-Hole Hemispherical Shell 68mm R3 Multi-Hole Hemispherical Shell 70mm R3 Multi-Hole Hemispherical Shell 72mm R3 Multi-Hole Hemispherical Shell 74mm R3 Multi-Hole Hemispherical Shell 76mm R3 Multi-Hole HA Coated Hemispherical Shell 44mm R3 Multi-Hole HA Coated Hemispherical Shell 46mm R3 Multi-Hole HA Coated Hemispherical Shell 48mm R3 Multi-Hole HA Coated Hemispherical Shell 50mm R3 Multi-Hole HA Coated Hemispherical Shell 52mm R3 Multi-Hole HA Coated Hemispherical Shell 54mm R3 Multi-Hole HA Coated Hemispherical Shell 56mm R3 Multi-Hole HA Coated Hemispherical Shell 58mm R3 Multi-Hole HA Coated Hemispherical Shell 60mm R3 Multi-Hole HA Coated Hemispherical Shell 62mm R3 Multi-Hole HA Coated Hemispherical Shell 64mm R3 Multi-Hole HA Coated Hemispherical Shell 66mm R3 Multi-Hole HA Coated Hemispherical Shell 68mm R3 Multi-Hole HA Coated Hemispherical Shell 70mm R3 Multi-Hole HA Coated Hemispherical Shell 72mm R3 Multi-Hole HA Coated Hemispherical Shell 74mm R3 Multi-Hole HA Coated Hemispherical Shell 76mm R3 Acetabular Shell Trial 40mm R3 Acetabular Shell Trial 41mm R3 Acetabular Shell Trial 42mm R3 Acetabular Shell Trial 43mm R3 Acetabular Shell Trial 44mm R3 Acetabular Shell Trial 45mm R3 Acetabular Shell Trial 46mm R3 Acetabular Shell Trial 47mm R3 Acetabular Shell Trial 48mm R3 Acetabular Shell Trial 49mm R3 Acetabular Shell Trial 50mm R3 Acetabular Shell Trial 51mm R3 Acetabular Shell Trial 52mm R3 Acetabular Shell Trial 53mm R3 Acetabular Shell Trial 54mm R3 Acetabular Shell Trial 55mm R3 Acetabular Shell Trial 56mm R3 Acetabular Shell Trial 57mm R3 Acetabular Shell Trial 58mm R3 Acetabular Shell Trial 59mm R3 Acetabular Shell Trial 60mm R3 Acetabular Shell Trial 61mm R3 Acetabular Shell Trial 62mm R3 Acetabular Shell Trial 63mm R3 Acetabular Shell Trial 64mm
Model Identifier(s)
71335540 71335542 71335544 71335546 71335548 71335550 71335552 71335554 71335556 71335558 71335560 71335562 71335564 71338662 71338663 71338664 71338665 71338666 71338667 71338668 71338669 71338671 71338672 71338673 71338674 71338675 71338676 71338677 71338678 71338731 71338732 71338733 71338734 71338735 71338736 71338737 71338738 71338739 71338740 71338741 71338742 71338743 71338744 71338745 71338747 71338749 71360740 71360741 71360742 71360743 71360744 71360745 71360746 71360747 71360748 71360749 71360750 71360751 71360752 71360753 71360754 71360755 71360756 71360757 71360758 71360759 71360760 71360761 71360762 71360763 71360764