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510(k) Data Aggregation

    K Number
    K211614
    Device Name
    CenterMed Patient Matched Assisted Surgical Planning (ASP) System
    Manufacturer
    CenterMed, Inc.
    Date Cleared
    2022-08-04

    (435 days)

    Product Code
    PBF, LLZ
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models of the Fibula and Ilium, surgical guides for harvesting bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
    Device Description
    CenterMed Patient Matched Assisted Surgical Planning (ASP) System is a combination of software design and additive manufacturing for customized virtual pre-surgical treatment planning in Maxillofacial reconstructive surgeries. The system processes patients' imaging data files obtained from the surgeons for treatment planning and outputs various patient-specific products (both physical and digital), including surgical guides for harvesting bone grafts from the Fibula or Ilium, anatomical models of the Fibula and Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. The physical products (surgical guides, anatomical models) are manufactured with biocompatible polyamide (PA-12) using additive manufacturing (Selective Laser Sintering).
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    K Number
    K201353
    Device Name
    CenterMed Patient Matched Assisted Surgical Planning (ASP) System
    Manufacturer
    CenterMed, Inc.
    Date Cleared
    2021-06-28

    (403 days)

    Product Code
    DZJ, LLZ
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical splints and surgical planning case reports for use in maxillofacial surgery. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
    Device Description
    CenterMed Patient Matched Assisted Surgical Planning (ASP) System is a combination of software design and additive manufacturing for customized virtual pre-surgical treatment planning in maxillofacial reconstruction and orthognathic surgeries. The system processes patients' imaging data files obtained from the surgeons for treatment planning and outputs various patient-specific products (both physical and digital), including surgical guides, anatomical models, surgical splints, and surgical planning case reports. The physical products (surgical guides, anatomical models and surgical splints) are manufactured with biocompatible polyamide (PA-12) using additive manufacturing (Selective Laser Sintering).
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