Total Hip replacement system
- UID
- IMP/MD/2020/000070_c0aa1ca53a245f19a42149602a09a398_b40d789c7f2f0446b00bf363b432d899
- Device class
- Class C
- Brand name
- Antibiotic Simplex
- License holder
- M/s Stryker India Private Ltd.,
- Approving authority
- CDSCO
- Product information
- The indications for use for total hip arthroplasty include: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. • Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum. Stryker’s Exeter X3 RimFit Acetabular Cup is intended for cemented use only. Stryker THR All-Polyethylene Acetabular Cups are intended for cemented use only
Total Hip replacement system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000070_c0aa1ca53a245f19a42149602a09a398_b40d789c7f2f0446b00bf363b432d899. This device is marketed under the brand name Antibiotic Simplex. The license holder is M/s Stryker India Private Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.