Femoral Stem with head - India CDSCO Medical Device Registration

Femoral Stem with head is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000137_b83d3eb5528f03238dbb32a510605909_9445b3b13ae2cfe0a869e44fcfed3430. This device is marketed under the brand name BOND+WELL . The license holder is BOND+WELL ORTHO PRODUCTS, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

Femoral Stem with head

UID: MFG/MD/2021/000137_b83d3eb5528f03238dbb32a510605909_9445b3b13ae2cfe0a869e44fcfed3430

Brand Name

BOND+WELL

License Holder

BOND+WELL ORTHO PRODUCTS

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Bipolar Hip Replacement System and are intended for use in partial hip arthroplasty & are intended for Cemented or Uncemented use. Partial hip arthroplasty is reliable and effective treatment option for hip fractures and diseased femoral heads and/or necks. The Bipolar shell articulates against the host acetabular articular cartilage, preserving acetabular bone stock for future considerations. Modular Hip Replacement System and are intended for use in total hip arthroplasty & are intended for cemented and/or Uncemented use. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components