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510(k) Data Aggregation
K Number
K212729Device Name
Bone Cement-Normal Viscosity
Manufacturer
Biomecanica Industria e Comerciode Produtos Ortopedicos LTDA
Date Cleared
2022-05-31
(277 days)
Product Code
LOD
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
Biomecanica Industria e Comerciode Produtos Ortopedicos LTDA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bone Cement - Normal Viscosity is indicated for fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions in cases of rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe secondary destruction of the joints after trauma or other conditions and in the review of previous arthroplasty procedures.
Device Description
The Bone Cement - Normal Viscosity is a self-curing, radiopaque, polymethyl methacrylatebased cements used for securing a metal or polymeric prothesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but rely instead on close mechanical interlock between the irregular bone surface and the prosthesis.
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