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Singapore HSA registration DE0509624

Howmedica Osteonics Biolox delta Universal Taper Femoral Head

Singapore flagSingapore·CLASS C·Howmedica Osteonics Corp.·Registered August 06, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0509624
Registration Date
August 06, 2024
Change Notification Approval Date
February 12, 2025
Retention Due Date
August 05, 2025
Product description
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 is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
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)
UNIVERSAL C-TAPER ADAPTER SLEEVE, OFFSET +0MM UNIVERSAL C-TAPER ADAPTER SLEEVE, OFFSET +5MM UNIVERSAL C-TAPER ADAPTER SLEEVE, OFFSET +2.5MM UNIVERSAL C-TAPER ADAPTER SLEEVE, OFFSET -2.5MM BIOLOX DELTA UNIVERSAL TAPER FEMORAL HEAD, OD 28MM BIOLOX DELTA UNIVERSAL TAPER FEMORAL HEAD, OD 32MM BIOLOX DELTA UNIVERSAL TAPER FEMORAL HEAD, OD 36MM BIOLOX DELTA UNIVERSAL TAPER FEMORAL HEAD, OD 40MM BIOLOX DELTA UNIVERSAL TAPER FEMORAL HEAD, OD 44MM UNIVERSAL V40 TAPER ADAPTER SLEEVE, OFFSET -2.5MM UNIVERSAL V40 TAPER ADAPTER SLEEVE, OFFSET +0MM UNIVERSAL V40 TAPER ADAPTER SLEEVE, OFFSET +4MM
Model Identifier(s)
19-0000T 19-0005T 19-0025T 19-0325T 6519-1-028 6519-1-032 6519-1-036 6519-1-040 6519-1-044 6519-T-025 6519-T-100 6519-T-204
About this record

Access comprehensive regulatory information for Howmedica Osteonics Biolox delta Universal Taper Femoral Head in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509624 and owned by Howmedica Osteonics Corp.. The device was registered on August 06, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C