Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250446
    Device Name
    Frida™ Anterior Cervical Plate System
    Manufacturer
    SpineUp, Inc.
    Date Cleared
    2025-05-23

    (98 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    SpineUp, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Frida™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine in skeletally mature patients, serving as an adjunct to fusion of the cervical spine (C2 - T1). The system is intended for the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: 1) degenerative disc disease (as defined as neck pain of discogenic origin and confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) spinal stenosis, 4) trauma, 5) failed previous fusions, 6) tumors, 7) curvature deformities (kyphosis, lordosis, or scoliosis), and/or 8) pseudoarthrosis.
    Device Description
    The Frida™ Anterior Cervical Plate System is an anterior cervical plating system that consists of single-use plates and screws, along with manual instruments for implant insertion. The plates are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and come in a variety of lengths to accommodate individual pathology and anatomical conditions of the patient. Plates incorporate a graft window for intraoperative visualization. Screws are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and are available in self-tapping and self-drilling options. Screws are available in a fixed or variable configuration, with a range of sizes to accommodate individual pathology. Plates and screws are available in single-use sterile packaging.
    Ask a Question

    Page 1 of 1