BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STRYKER 2115 REPLACEMENT BATTERY (2115)

    K Number: K970378 · Decision Apr 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    28
    Applicant Total
    2
    Review Days
    89

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    STRYKER 2115 REPLACEMENT BATTERY (2115)
    K Number
    K970378
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Implant Resource, Inc.
    Date Received
    January 31, 1997
    Decision Date
    April 30, 1997
    Product Code
    KIJ
    Advisory Committee
    General, Plastic Surgery
    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
    KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

    Similar 510(k) Clearances

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

    SMARTO

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    INSURGICAL SINGLE USE POWER EQUIPMENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SMARTO

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ACUMED BONE GRAFT SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Implant Resource, Inc.

    K Number Device Name
    K002125 PINS AND WIRES