LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K032891
    Device Name
    TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
    Manufacturer
    TRANS1, INC.
    Date Cleared
    2004-01-15

    (120 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K983995,K984365,K990715,K990974,K991444,K993679,K011116,K012808,K023249
    Why did this record match?
    Device Name :

    TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT

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

    The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5-S1 interbody fusion.

    Device Description

    The Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior lower spine and consists of the following components: Guide Pin Introducer Guide Pins Dilators Dilators with sheath Guide Pin Steering Handle Twist Drills Cutters Brushs Exchange Rod Exchange Cannula Brush Delivery Sleeve Distraction Tool with driver Bone Graft Inserter Fibula Placement Tool

    AI/ML Overview

    This document is a 510(k) summary for the TranS1 Trans-Sacral Spinal Access and Preparation Device, and thus does not contain information on acceptance criteria or a study proving device performance against such criteria.

    The 510(k) summary states the following about the device:

    • Device Name: TranS1 Trans-Sacral Spinal Access and Preparation Device (also referred to as TranS1 Trans-Sacral Spinal Access and Preparation Kit)
    • Generic Name: Rigid Endoscope and Instrument Set
    • Intended Use/Indications for Use: For minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L5-S1 interbody fusion.
    • Technological Characteristics: Designed to gain a minimally invasive access tract to the anterior region of the lower spine and assist in the diagnosis and treatment of the area, enabling procedures such as biopsy, lumbar fusion, vertebroplasty, etc. Access up to L5 is possible.
    • Predicate Devices:
      • AxiaMed, Inc., Trans-Sacral Spinal Access Device
      • Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit
      • Argus Medical Company Laparoscopic Discectomy Instrument System
      • Surgical Dynamics, Inc., Nucleotome Tissue Aspirator/Cutter
      • Surgical Dynamics, Inc., Nucleotome II Tissue Aspirator/cutter
      • Sofamor Danek Mfg., Inc., Danek Tissue Cutting and Removal System
      • United States Surgical, Auto Suture Spinal Elevator
      • Harrington Spinal Elevator
      • Karlin Technology, Inc., Cobb Spinal Elevator.

    The document is primarily focused on demonstrating substantial equivalence to these predicate devices for market clearance, rather than presenting a performance study with defined acceptance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this filing.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1