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510(k) Data Aggregation

    K Number
    K181584
    Device Name
    Redi-Spine
    Manufacturer
    Innovative Surgical Designs, Inc.
    Date Cleared
    2018-08-10

    (56 days)

    Product Code
    NKB,KWP
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Redi-Spine

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Redi-Spine is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, syphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

    When used for posterior non-cervical pediatic patients, the Redi-Spine is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis. Additionally, the Redi-Spine is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach. The Redi-Spine is intended to be used with autograft and/or allograft.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Redi-Spine Thoracolumbosacral pedicle screw system, indicating it has been found substantially equivalent to a legally marketed predicate device. This type of document describes the intended use and regulatory classification of the device, but it does not contain information about acceptance criteria or the study that proves the device meets specific performance criteria.

    Therefore, I cannot extract the requested information from the provided text. The document does not include details on:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size for the test set or data provenance.
    3. Number of experts used to establish ground truth or their qualifications.
    4. Adjudication method for the test set.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
    6. Results of a standalone algorithm-only performance study.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How the ground truth for the training set was established.
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