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

    REPLACEMENT SAW BLADES FOR STRYKER AIR

    K Number: K820601 · Decision Mar 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    304
    Registration Numbers
    304
    Same Product Code
    26
    Applicant Total
    40
    Review Days
    18

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    Basic Information

    Device Name
    REPLACEMENT SAW BLADES FOR STRYKER AIR
    K Number
    K820601
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Micro-Aire Surgical Instruments, Inc.
    Date Received
    March 5, 1982
    Decision Date
    March 23, 1982
    Product Code
    GFA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GFA Blade, Saw, General & Plastic Surgery, Surgical

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    Other Clearances by Micro-Aire Surgical Instruments, Inc.

    K Number Device Name
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    K902676 MICROGUARD, ORTHOPEDIC PIN PROTECTORS
    K903650 OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
    K903664 MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
    K901967 DENDIA WERK BURS AND CUTTING DISCS
    K901735 ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444
    K902168 ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
    K900033 MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
    K900210 BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
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