HSA · registration DE0509624Howmedica Osteonics Biolox delta Universal Taper Femoral Head
- Registration number
- DE0509624
- Model name
- 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
- 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
- Registration date
- August 06, 2024
- Source update date
- December 12, 2024
- Risk class
- Class C
- Product owner
- Howmedica Osteonics Corp.
- Registrant / registration holder
- STRYKER SINGAPORE PRIVATE LIMITED
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 address
- 325 Corporate Drive, Mahwah, NJ 07430, United States
- Registrant address
- 38 BEACH ROAD, #23-11, SOUTH BEACH TOWER, Singapore 189767
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.