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

    ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS

    K Number: K940290 · Decision Sep 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    78
    Review Days
    250

    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
    ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS
    K Number
    K940290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acufex Microsurgical, Inc.
    Date Received
    January 21, 1994
    Decision Date
    September 28, 1994
    Product Code
    HRX
    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
    HRX Arthroscope

    Similar 510(k) Clearances

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

    Digital ClarusScope System and Digital NeuroPEN System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Freedom DS™ Decompression System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VantageTM Lumbar Decompression Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PUREVUE™ FMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Articulator Arthroscopic Bur

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

    Other Clearances by Acufex Microsurgical, Inc.

    K Number Device Name
    K961555 ACUFEX TAG BIOABSORBABLE ANCHORS
    K961853 PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
    K954246 ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
    K952535 ACUFEX ENDOBUTTON TAPE
    K953276 ACUFEX TAG DELIVERY SYSTEM
    K953459 ACUFEX TAG ANCHOR
    K941740 ACUFEX ROTATOR CUFF FIXATION BUTTON
    K944500 ACUFEX PATELLAR BONE BLOCK SIZER
    K951859 ACUFEX ENDOBUTTON PACK
    K946346 ACUFEX TAG(R) BIOABSORBABLE ANCHORS
    Search all 78 clearances from Acufex Microsurgical, Inc. →