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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: MQN FDA class 2

    External Mandibular Fixator And/Or Distractor

    Dental

    View full classification →

    The External Mandibular Fixator and/or Distractor is a dental implant device used externally to stabilize jaw fractures or to gradually distract (lengthen) the mandible through the process of distraction osteogenesis in patients with jaw deformities or after tumor resection. Classified as FDA Class 2 under 21 CFR 872.4760 in the Dental specialty, it requires 510(k) premarket notification. The product code is MQN, and it carries an implant flag.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    KLS Martin IPS Distraction
    DePuy Synthes Maxillofacial Portfolio - MR Conditional
    Stryker Pediatric Mandibular Distractor 2
    Craniomaxillofacial Distraction System (CMFD)
    Internal Distraction - Sterile
    Mandible External Fixator - MR Conditional
    STRYKER PEDIATRIC MANDIBLE DISTRACTOR
    SYNTHES CURVILINEAR DISTRACTION SYSTEM
    MIS CREST WIDENER
    DISTRAX
    SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
    KLS MARTIN XTERNAL FIXATOR
    STRYKER EXTERNAL FIXATION SYSTEM
    CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE
    OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM
    OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED
    SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
    SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
    MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM
    SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
    SYNTHES MANDIBLE EXTERNAL FIXATOR
    OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM
    ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)
    SYNTHES MANDIBLE EXTERNAL FIXATOR
    SYNTHES EXTERNAL MIDFACE DISTRACTOR
    ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4
    KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
    NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
    OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM
    KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
    SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
    OSTEOMED ALVEOLAR DISTRACTION SYSTEM
    LORENZE EXTERNAL MANDIBULAR DISTRACTOR
    DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3
    INTRAORAL MANDIBULAR DISTRACTION SYSTEM
    LORENZ BLUE DEVICE
    ZURICH DISTRACTION SYSTEM
    TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION
    ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
    MACROPOREDX DISTRACTOR SYSTEM
    INTER-OS BONE GENERATOR
    LORENZ DISTRACTION SYSTEM
    LORENZ EXTERNAL MANDIBULAR DISTRACTOR
    K-L-W INTRAORAL DISTRACTOR
    OSTEOMED INTRAORAL DISTRACTION SYSTEM
    INNOVA TELESCOPIC DISTRACTOR
    KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR
    KLS INTRAORAL VERTICAL DISTRACTOR
    LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
    LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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