Singapore HSA registration DE0507831

Stryker Restoration Acetabular Wedge Augment

Singapore·CLASS C·Howmedica Osteonics Corp.·Registered March 01, 2023

Device classification

Device Class: CLASS C
Medical Speciality Area: Orthopaedics

Registration information

Registration Number: DE0507831
Registration Date: March 01, 2023
Change Notification Approval Date: October 04, 2023
Retention Due Date: February 28, 2026

Product description

General Indications - 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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 is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. Indications specific to the Acetabular Wedges - As an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies.

Product Owner

Name: Howmedica Osteonics Corp.
Short Name: Howmedica
Address: 325 Corporate Drive, Mahwah, NJ 07430, UNITED STATES

Registrant

Name: STRYKER SINGAPORE PRIVATE LIMITED
Address: 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145

Importer

Name: STRYKER SINGAPORE PRIVATE LIMITED
Address: 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145

Model information

Model Name(s): RESTORATION ACETABULAR WEDGE AUGMENT 46MM OD, 48MM ID, THICKNESS 15MM RESTORATION ACETABULAR WEDGE AUGMENT 46MM OD, 48MM ID, THICKNESS 20MM RESTORATION ACETABULAR WEDGE AUGMENT 46MM OD, 48MM ID, THICKNESS 25MM RESTORATION ACETABULAR WEDGE AUGMENT 50MM OD, 52MM ID, THICKNESS 15MM RESTORATION ACETABULAR WEDGE AUGMENT 50MM OD, 52MM ID, THICKNESS 20MM RESTORATION ACETABULAR WEDGE AUGMENT 50MM OD, 52MM ID, THICKNESS 25MM RESTORATION ACETABULAR WEDGE AUGMENT 54MM OD, 56MM ID, THICKNESS 15MM RESTORATION ACETABULAR WEDGE AUGMENT 54MM OD, 56MM ID, THICKNESS 20MM RESTORATION ACETABULAR WEDGE AUGMENT 54MM OD, 56MM ID, THICKNESS 25MM RESTORATION ACETABULAR WEDGE AUGMENT 58MM OD, 60MM ID, THICKNESS 15MM RESTORATION ACETABULAR WEDGE AUGMENT 58MM OD, 60MM ID, THICKNESS 20MM RESTORATION ACETABULAR WEDGE AUGMENT 58MM OD, 60MM ID, THICKNESS 25MM RESTORATION ACETABULAR WEDGE AUGMENT 62MM OD, 64MM ID, THICKNESS 15MM RESTORATION ACETABULAR WEDGE AUGMENT 62MM OD, 64MM ID, THICKNESS 20MM RESTORATION ACETABULAR WEDGE AUGMENT 62MM OD, 64MM ID, THICKNESS 25MM RESTORATION ACETABULAR WEDGE AUGMENT 66MM OD, 68MM ID, THICKNESS 15MM RESTORATION ACETABULAR WEDGE AUGMENT 66MM OD, 68MM ID, THICKNESS 20MM RESTORATION ACETABULAR WEDGE AUGMENT 66MM OD, 68MM ID, THICKNESS 25MM RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 46MM OD, 48MM ID, 15MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 46MM OD, 48MM ID, 20MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 46MM OD, 48MM ID, 25MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 50MM OD, 52MM ID, 15MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 50MM OD, 52MM ID, 20MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 50MM OD, 52MM ID, 25MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 54MM OD, 56MM ID, 15MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 54MM OD, 56MM ID, 20MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 54MM OD, 56MM ID, 25MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 58MM OD, 60MM ID, 15MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 58MM OD, 60MM ID, 20MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 58MM OD, 60MM ID, 25MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 62MM OD, 64MM ID, 15MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 62MM OD, 64MM ID, 20MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 62MM OD, 64MM ID, 25MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 66MM OD, 68MM ID, 15MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 66MM OD, 68MM ID, 20MM THICK RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 66MM OD, 68MM ID, 25MM THICK
Model Identifier(s): 5096-4615 5096-4620 5096-4625 5096-5015 5096-5020 5096-5025 5096-5415 5096-5420 5096-5425 5096-5815 5096-5820 5096-5825 5096-6215 5096-6220 5096-6225 5096-6615 5096-6620 5096-6625 5097-4615 5097-4620 5097-4625 5097-5015 5097-5020 5097-5025 5097-5415 5097-5420 5097-5425 5097-5815 5097-5820 5097-5825 5097-6215 5097-6220 5097-6225 5097-6615 5097-6620 5097-6625

About this record

Access comprehensive regulatory information for Stryker Restoration Acetabular Wedge Augment in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507831 and owned by Howmedica Osteonics Corp.. The device was registered on March 01, 2023.

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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