BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    BRM Digitalis Spacer

    K Number: K220142 · Decision Apr 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    441

    Basic Information

    Device Name
    BRM Digitalis Spacer
    K Number
    K220142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3230
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brm Extremities Srl
    Date Received
    January 18, 2022
    Decision Date
    April 4, 2023
    Product Code
    KYJ
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KYJ Prosthesis, Finger, Constrained, Polymer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KYJ), ordered by most recent decision date.

    Ascension Silicone MCP; Ascension Silicone PIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KeriFlex® MCP and PIP Finger Joint Prostheses

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSTEOTEC SILICONE FINGER IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO DEPUY NEUFLEX PIP FINGER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASCENSION SILICONE PIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASCENSION SILLICONE MCP

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Brm Extremities Srl

    K Number Device Name
    K203773 BRM TOOL Screws