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510(k) Data Aggregation
K Number
K222106Device Name
Waypoint GPS
Manufacturer
Date Cleared
2023-05-12
(298 days)
Product Code
Regulation Number
874.1820Why did this record match?
Product Code :
QWP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Waypoint GPS™ is indicated for use during pedicle screw pilot hole drilling to provide visual feedback to the surgeon of changes in color to the tissue at the tip of the probe that may indicate contact with soft tissues and possible vertebral cortex perforation. The Waypoint GPS™ is indicated for use in both open and percutaneous (MIS) procedures.
Device Description
The Waypoint GPS™ is comprised of a single use, disposable device and a software application that is downloaded onto the provided tablet. The system is intended to surgeons during pilot hole drilling for pedicle screw placement. Waypoint GPS™ probe is single use disposable and consists of a handle containing electronics and a stainless-steel shaft with distal LED and fiber optics for visualizing the tissues immediately in contact with the distal end of the probe. The device produces visual signals to indicate changes in color associated with possible verforation. It uses light to provide visual alerts to indicate a change in anatomical structure to prevent placement in soft tissues or vertebral cortex perforation.
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