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Stryker Exeter X3 RimFit Cups. - HSA Registration DE0509095

Access comprehensive regulatory information for Stryker Exeter X3 RimFit Cups. in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509095 and owned by Howmedica Osteonics Corp.. The device was registered on March 22, 2024.

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
DE0509095
Stryker Exeter X3 RimFit Cups.
HSA Registration Number: DE0509095
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Product Description

The indications for use for total hip arthroplasty include: 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure; 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results; 4. Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum. Strykerโ€™s Exeter X3 RimFit Cup is intended for cemented use only.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0509095
Registration Date
March 22, 2024
Retention Due Date
March 21, 2026
Product Owner
Short Name
Howmedica
Address
325 Corporate Drive, Mahwah, NJ 07430, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
EXETER X3 RIMFIT CUP OD: 40MM, ID: 22.2MM EXETER X3 RIMFIT CUP OD: 42MM, ID: 22.2MM EXETER X3 RIMFIT CUP OD: 44MM, ID: 22.2MM EXETER X3 RIMFIT CUP OD: 44MM, ID: 28MM EXETER X3 RIMFIT CUP OD: 46MM, ID: 28MM EXETER X3 RIMFIT CUP OD: 48MM, ID: 28MM EXETER X3 RIMFIT CUP OD: 50MM, ID: 28MM EXETER X3 RIMFIT CUP OD: 52MM, ID: 28MM EXETER X3 RIMFIT CUP OD: 54MM, ID: 28MM EXETER X3 RIMFIT CUP OD: 56MM, ID: 28MM EXETER X3 RIMFIT CUP OD: 58MM, ID: 28MM EXETER X3 RIMFIT CUP OD: 60MM, ID: 28MM EXETER X3 RIMFIT CUP OD: 48MM, ID: 32MM EXETER X3 RIMFIT CUP OD: 50MM, ID: 32MM EXETER X3 RIMFIT CUP OD: 52MM, ID: 32MM EXETER X3 RIMFIT CUP OD: 54MM, ID: 32MM EXETER X3 RIMFIT CUP OD: 56MM, ID: 32MM EXETER X3 RIMFIT CUP OD: 58MM, ID: 32MM EXETER X3 RIMFIT CUP OD: 60MM, ID: 32MM EXETER X3 RIMFIT CUP OD: 52MM, ID: 36MM EXETER X3 RIMFIT CUP OD: 54MM, ID: 36MM EXETER X3 RIMFIT CUP OD: 56MM, ID: 36MM EXETER X3 RIMFIT CUP OD: 58MM, ID: 36MM EXETER X3 RIMFIT CUP OD: 60MM, ID: 36MM EXETER X3 RIMFIT CUP OD: 56MM, ID: 40MM EXETER X3 RIMFIT CUP OD: 58MM, ID: 40MM EXETER X3 RIMFIT CUP OD: 60MM, ID: 40MM
Model Identifier(s)
7309-2-240 7309-2-242 7309-2-244 7309-2-844 7309-2-846 7309-2-848 7309-2-850 7309-2-852 7309-2-854 7309-2-856 7309-2-858 7309-2-860 7309-3-248 7309-3-250 7309-3-252 7309-3-254 7309-3-256 7309-3-258 7309-3-260 7309-3-652 7309-3-654 7309-3-656 7309-3-658 7309-3-660 7309-4-056 7309-4-058 7309-4-060