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

    JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS

    K Number: K141219 · Decision Jul 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    272
    Registration Numbers
    272
    Same Product Code
    92
    Applicant Total
    93
    Review Days
    67

    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
    JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS
    K Number
    K141219
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Manufacturing Corp
    Date Received
    May 12, 2014
    Decision Date
    July 18, 2014
    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 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 →