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

    AMS MAINSTAY UROLOGIC BONE ANCHOR

    K Number: K971332 · Decision Jul 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    72
    Review Days
    90

    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
    AMS MAINSTAY UROLOGIC BONE ANCHOR
    K Number
    K971332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Systems, Inc.
    Date Received
    April 10, 1997
    Decision Date
    July 9, 1997
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

    Similar 510(k) Clearances

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

    Dione PEEK Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Y-Knotless™ Flex Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Anchor with Fiber Wire and Disposable Inserter

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArthroTAK Tendon Anchor Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex FiberTak Suture Anchor

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

    Other Clearances by American Medical Systems, Inc.

    K Number Device Name
    K132655 RETROARC RETROPUBIC SLING SYSTEM
    K112842 AMS ELEVATE PC
    K100807 MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
    K092735 GREENLIGHT XPS LASER SYSTEM
    K090934 PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
    K090663 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
    K090713 ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
    K082677 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
    K082730 AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
    K082006 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
    Search all 72 clearances from American Medical Systems, Inc. →