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FDA 510(k)

MedCAD® AccuStride™ System

K-Number: K241811 · 2025-03-13

ApplicantMedcad
Decision Date2025-03-13
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MedCAD® AccuStride™ System is a medical device manufactured by Medcad. It received FDA 510(k) clearance on 2025-03-13 under approval number K241811. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MedCAD® AccuStride™ System?

MedCAD® AccuStride™ System is a medical device that received FDA 510(k) clearance on 2025-03-13. It is manufactured by Medcad. The 510(k) number is K241811.

When was MedCAD® AccuStride™ System approved by the FDA?

MedCAD® AccuStride™ System received FDA 510(k) clearance on 2025-03-13, under approval number K241811.

What company makes MedCAD® AccuStride™ System?

MedCAD® AccuStride™ System is manufactured by Medcad.

What is the FDA product code for MedCAD® AccuStride™ System?

The FDA product code for MedCAD® AccuStride™ System is PBF.

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Related Devices (Code: PBF)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.