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

    DEPUY ACE COMPOSITE LOCKING NUT

    K Number: K983265 · Decision Oct 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    272
    Registration Numbers
    272
    Same Product Code
    92
    Applicant Total
    10
    Review Days
    39

    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
    DEPUY ACE COMPOSITE LOCKING NUT
    K Number
    K983265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Ace Medical Co.
    Date Received
    September 17, 1998
    Decision Date
    October 26, 1998
    Product Code
    HTN
    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
    HTN Washer, Bolt Nut

    Similar 510(k) Clearances

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

    LARS ACJ

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SportLinc Syndesmosis Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Syndesmosis TightRope PRO

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Synchfix EVT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RipCord

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Acu-Sinch Knotless Mini

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

    Other Clearances by Depuy Ace Medical Co.

    K Number Device Name
    K990392 DEPUY ACE SPIDER PLATE
    K990120 MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
    K984458 DEPUY ACE SPIDER PLATE
    K983853 DEPUY ACE TIMAX META PLATE
    K982347 DEPUY ACE TIMAX PILON PLATE
    K981775 DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE
    K974245 DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI
    K970503 DEPUY ACE TROCHANTERIC SIDE PLATE
    K970202 DEPUY ACE AIM TITANIUM TIBIAL NAIL