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510(k) Data Aggregation

    K Number
    K062371
    Device Name
    PREVIEW ANTERIOR CERVICAL PLATE SYSTEM
    Manufacturer
    ALPHASPINE, INC.
    Date Cleared
    2006-12-04

    (112 days)

    Product Code
    KWQ,KWO
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALPHASPINE, INC.

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

    The PreView™ Anterior Ccrvical Plate System is intended for the treatment of the cervical spine in skeletally mature patients.receiving fusion-by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The PreView™ Anterior Cervical Plate System is intended for use under the following indications: )
    · Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
    • Spondylolisthesis

    • · Trauma (i.e., fracture or dislocation)
      · Spinal stenosis
    • · Deformitics or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
      • Tumor
    • Pseudoarthrosis
    • · Failed previous fusion
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "PreView™ Anterior Cervical Plate System." It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain information regarding acceptance criteria or a study proving that the device meets acceptance criteria.

    Instead, it pertains to the regulatory clearance process, specifically detailing:

    • Device Name: PreView™ Anterior Cervical Plate System
    • Applicant: Alphaspine, Incorporated
    • FDA Decision Date: December 4, 2006
    • Regulation Number and Name: 21 CFR 888.3060, Spinal intervertebral body fixation orthosis
    • Regulatory Class: II
    • Product Code: KWO
    • Indications for Use: Treatment of the cervical spine (C2-T1) in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft, with removal of implants after solid fusion. Specific indications include Degenerative disc disease (DDD), Spondylolisthesis, Trauma (fracture or dislocation), Spinal stenosis, Deformities or curvatures (scoliosis, kyphosis, lordosis), Tumor, Pseudoarthrosis, and Failed previous fusion.

    Therefore, I cannot provide the requested information about acceptance criteria and study details based on the provided text. This document is a regulatory approval, not a scientific study report.

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