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

    PIP Fix

    K Number: K181192 · Decision Oct 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    84
    Applicant Total
    9
    Review Days
    171

    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
    PIP Fix
    K Number
    K181192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hand Biomechanics Lab, Inc.
    Date Received
    May 4, 2018
    Decision Date
    October 22, 2018
    Product Code
    JEC
    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
    JEC Component, Traction, Invasive

    Similar 510(k) Clearances

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

    SteriTrak

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Anjon Bremer Halo System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DigiFix Sterile Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Anjon Bremer Halo System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Medline ReNewal Reprocessed Stryker External Fixation Devices

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIGIFIX EXTERNAL FIXATION SYSTEM

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

    Other Clearances by Hand Biomechanics Lab, Inc.

    K Number Device Name
    K252020 TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
    K222490 HBL Blade Assembly
    K072432 F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
    K033112 WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS
    K030519 WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
    K992970 DIGIT WIDGET
    K984442 AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
    K942906 AGEE-WRISTJACK PRE-DRILL KIT