BEUDAMED
    Product Code: HTJ FDA class 1 21 CFR 888.4300

    Gauge, Depth

    Orthopedic

    A depth gauge is a surgical measuring instrument used in orthopedic procedures to determine the depth of a hole drilled in bone, ensuring correct screw or implant length selection. It is classified as an FDA Class 1 device under 21 CFR 888.4300, indicating low risk and general controls only. Product code HTJ falls under the Orthopedic medical specialty.

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    510(k)s
    4
    FEI Numbers
    372
    Registration Numbers
    372
    Unique Applicants
    3
    Years Active
    7

    Basic Information

    Product Code
    HTJ
    Device Class
    FDA class 1
    Regulation Number
    888.4300
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K940480 ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE
    K925335 ACUFEX INTRA ARTICULAR MEASURING DEVICE
    K873191 ACROMED INTERBODY DEPTH GAUGES
    K864426 RAYLOR(TM) DEPTH GAUGE

    FEI Numbers

    This FDA classification entry is associated with 372 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 372 registration numbers. Click on an entry to view related FDA registrations.