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510(k) Data Aggregation

    K Number
    K252088
    Device Name
    Firebird SI Navigation System
    Manufacturer
    Orthofix US LLC
    Date Cleared
    2025-10-31

    (121 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K251772
    Device Name
    Navilas Laser System 577sl (156691)
    Manufacturer
    OD-OS GmbH
    Date Cleared
    2025-10-29

    (141 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252393
    Device Name
    VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
    Manufacturer
    Ortho-Clinical Diagnostics, Inc.
    Date Cleared
    2025-10-29

    (90 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250520
    Device Name
    OsteoCentric Navigated Instruments System
    Manufacturer
    OsteoCentric Technologies, Inc.
    Date Cleared
    2025-10-27

    (248 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252646
    Device Name
    Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2025-10-24

    (64 days)

    Product Code
    FCG
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250409
    Device Name
    Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2025-10-21

    (250 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250945
    Device Name
    Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2025-10-17

    (203 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252247
    Device Name
    Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2025-10-16

    (90 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252920
    Device Name
    ELEOS™ Limb Salvage System with NanoCept® Technology
    Manufacturer
    Onkos Surgical, Inc.
    Date Cleared
    2025-10-15

    (33 days)

    Product Code
    QZZ
    Regulation Number
    888.3900
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K243078
    Device Name
    HexaPLUS S OneDrill Implant System
    Manufacturer
    Osseofuse International Inc.
    Date Cleared
    2025-10-10

    (375 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K131748,K110577,K181157
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HexaPLUS S OneDrill Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement-retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. The system is intended for delayed loading.

    Device Description

    The HexaPLUS S OneDrill Implant System is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the indications for use, the technology used, the material compositions and performance characteristics. The surface of the implants are treated by SLA method. Implants with 4.50mm and 5.25mm body diameter are provided in lengths of 8.5, 10, 11.5, 13.0, 14.5, and 16 mm. Implants with 6.5mm and 7.5mm body diameter are provided in lengths of 8.5, 10, 11.5, 13.0, and 14.5.

    The system includes the following components.

    Fixtures

    • Size: 4.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5/16.0mm (L)
    • 5.25mm (Dia.) x 8.5/10.0/11.5/13.0/14.5/16.0mm (L)
    • 6.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5
    • 7.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5

    Abutments

    • Healing Abutment
    • One-Step Abutment
    • Final Cement Abutment
    • Straight Abutment
    • Angled Abutment
    • Temporary Abutment
    • Ball Abutment

    Cover Screw

    • Size: 3.45mm (Dia.) x 4.9

    Abutment Screw

    • Size: 2.30mm (Dia.) x 8.25

    Multi Angle Abutment Screw

    • Size: 2.30mm (Dia.) x 8.20
    AI/ML Overview

    N/A

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