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510(k) Data Aggregation

    K Number
    K240461
    Device Name
    OsteoSinter® EVANS and COTTON wedges and related accessories
    Manufacturer
    Ames Medical Prosthetic Solutions, S.A.U.
    Date Cleared
    2024-12-06

    (294 days)

    Product Code
    PLF, HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ames Medical Prosthetic Solutions, S.A.U.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OsteoSinter® EVANS and COTTON wedges are intended to be used for internal bone fixation of bone fractures, fusions, or osteotomies in the foot. Specific Indications include: - Opening wedge osteotomies of the foot (including osteotomies for Hallux Valgus). - Opening wedge of Medial Cuneiform or Cotton osteotomies. - Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy). - Metatarsal/Cuneiform arthrodesis. OsteoSinter® EVANS and COTTON wedges are indicated for use with ancillary bone fixation. OsteoSinter® EVANS and COTTON wedges are not indicated for use in the spine
    Device Description
    The OsteoSinter® EVANS and COTTON wedges are sterile, single use porous titanium implantable wedges, available in varied footprints and heights, intended to be used for correction of foot deformities.
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