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

    COHORT AVB RETRACTOR SYSTEM

    K Number: K943472 · Decision Oct 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    373
    Registration Numbers
    373
    Same Product Code
    14
    Applicant Total
    5
    Review Days
    93

    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
    COHORT AVB RETRACTOR SYSTEM
    K Number
    K943472
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cohort Medical Products Group, Inc.
    Date Received
    July 19, 1994
    Decision Date
    October 20, 1994
    Product Code
    HXB
    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
    HXB Probe

    Similar 510(k) Clearances

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

    DIAO HAND SURGERY SET

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    SURGICAL PROBE

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    HOOK PROBE #TM-1376

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    BOWEN PROBE

    FDA 510(k)
    FDA Class 1 ·Orthopedic
    View all

    Other Clearances by Cohort Medical Products Group, Inc.

    K Number Device Name
    K964975 COHORT DISCECTOMY SYSTEMS (CDS)
    K950011 COHORT(TM) ANTERIOR PLATE SYSTEM (APS)
    K943804 BONE SCREW
    K943474 CANNULATED BONE SCREW