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510(k) Data Aggregation
K Number
K202914Device Name
SternaFuse Fixation System
Manufacturer
Date Cleared
2022-01-26
(484 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Fusion Innovations, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SternaFuse® Fixation System is indicated for use in the stabilization of fractures of the anterior chest wall, including stemal fixation following sternal fractures, and sternal reconstructive surgical procedures, to promote fusion. The device is for prescription use only.
Device Description
The SternaFuse® Fixation System implants are composed of 316 LVM implant quality stainless steel plates, links, and screws intended to stabilize and fixate fractures of the anterior chest wall. The components include various sizes to facilitate customization according to the requirements of the anterior chest wall repair. Self-drilling locking screws come in two diameters, 3.0mm and 3.3mm, and lengths of 10mm, 13mm, and 16mm. Multiple plates may be used in one anterior chest wall repair. Variable Assemblies can be configured, and the Links angled for optimum fixation. Implants are designed with centralized saddles to aid in intra-operative contouring, to facilitate cutting during postoperative emergent re-entry, and to provide a location for stainless steel wire.
The implants are individually packaged and sterilized, allowing the surgeon to customize the desired implants for the specific needs of the patient. All implants are provided sterile with a five-year shelf-life. The implants should never be reused under any circumstance.
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