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

    BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS

    K Number: K131135 · Decision Jan 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    18
    Applicant Total
    93
    Review Days
    275

    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
    BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
    K Number
    K131135
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Manufacturing Corp
    Date Received
    April 22, 2013
    Decision Date
    January 22, 2014
    Product Code
    MBB
    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
    MBB Bone Cement, Antibiotic

    Similar 510(k) Clearances

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

    SpaceFix Shoulder Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GENTAFIX® (1, 3, 3MV)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    StageOne™ Select Hip Cement Spacer Molds

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    StageOne™ Shoulder Cement Spacer Molds

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    StageOne Knee Cement Spacer Molds

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

    Other Clearances by Biomet Manufacturing Corp

    K Number Device Name
    K230540 Patient Specific Planning Solution™ 3D Bone Models
    K214001 Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
    K211729 Comprehensive® Convertible Glenoid - Vivacit-E Liner
    K202232 Comprehensive Vault Reconstruction System
    K193038 Comprehensive Shoulder System
    K182516 Comprehensive Nano Stemless Shoulder
    K181611 Comprehensive Reverse Shoulder System
    K173411 Comprehensive Segmental Revision System (SRS)
    K172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
    K163651 ExpressBraid Graft Manipulation
    Search all 93 clearances from Biomet Manufacturing Corp →