BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SP-LINK™ System

    K Number: K182352 · Decision Nov 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    47
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    SP-LINK™ System
    K Number
    K182352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Designs, LLC
    Date Received
    August 29, 2018
    Decision Date
    November 21, 2018
    Product Code
    PEK
    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
    PEK Spinous Process Plate

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    Other Clearances by Medical Designs, LLC

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    K090048 ASFORA BULLET CAGE SYSTEM
    K042359 SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
    K002970 SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901