A large lamina spreader with a very thin closed profile, designed to enable distraction in tight joint spaces like the subtalar and talonavicular joints
This device is not intended to provide quantitative measurements and does not incorporate a measuring function as defined under Regulation (EU) 2017/745 (MDR).
Any scales, markings, or visual indicators present on the device are provided solely for reference and orientation purposes to support general use. These indicators are not calibrated against traceable standards and have not been validated for accuracy, precision, or repeatability.
Accordingly, values derived from these markings shall be considered approximate only and must not be used where accurate or traceable measurements are required for clinical decision-making, diagnosis, or other applications requiring defined metrological performance.
Users shall rely only on devices specifically intended and validated for measurement when quantitative accuracy is required.