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510(k) Data Aggregation

    K Number
    K251969
    Device Name
    Atlas Spine Project X Expandable Posterior Lumbar Interbody System
    Manufacturer
    Atlas Spine, Inc.
    Date Cleared
    2025-08-15

    (50 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Atlas Spine Project X Expandable Posterior Lumbar Interbody System

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

    Atlas Spine Project X Expandable Posterior Lumbar Interbody Spacers are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

    Atlas Spine Project X Expandable Posterior Lumbar Interbody Spacers are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the Apelo™ Pedicle Screw System.

    Device Description

    Not Found

    AI/ML Overview

    The provided FDA 510(k) clearance letter for the "Atlas Spine Project X Expandable Posterior Lumbar Interbody System" does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria.

    The letter is a regulatory document confirming that the device has been reviewed and found substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, classification, and applicable regulations (such as Quality System regulations, UDI rules, and adverse event reporting).

    Therefore, I cannot provide the requested information from the given input because the document does not contain details about:

    1. Acceptance criteria and reported device performance.
    2. Sample size, data provenance, number of experts, or adjudication methods for any test set.
    3. MRMC comparative effectiveness study results.
    4. Standalone performance studies.
    5. Type of ground truth used.
    6. Training set sample size or how its ground truth was established.

    The letter mentions the "Indications for Use" for the device, detailing the patient population and conditions for which it is intended, but this is distinct from performance criteria and study results.

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