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FDA 510(k)

MedCAD® AccuStride™ System

K-Number: K252064 · 2026-03-27

ApplicantMedcad
Decision Date2026-03-27
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MedCAD® AccuStride™ System is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K252064. 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 2026-03-27. The listed applicant is Medcad. The 510(k) number is K252064.

When did MedCAD® AccuStride™ System receive FDA 510(k) clearance?

MedCAD® AccuStride™ System received FDA 510(k) clearance on 2026-03-27, under 510(k) number K252064.

Who is the listed applicant for MedCAD® AccuStride™ System?

The FDA 510(k) record lists Medcad as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Medcad as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251709MedCAD® AccuStride™ SystemK241811MedCAD® AccuStride™ SystemK230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemK223421MedCAD AccuPlan Orthopedics SystemK223024MedCAD AccuPlan SystemK220357MedCAD AccuShape Titanium Patient-Specific Cranial Implant

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Related Devices (Code: PBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250711VSP Orthopedics System3D Systems, Inc.K242603MyPAO SA guidesMedacta International S.A.K251709MedCAD® AccuStride™ SystemMedcadK250394Fine TTO™Bodycad Laboratories, Inc.K250767Newclip Patient-matched instrumentation non sterile PSINewclip TechnicsK250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.

Official Source

View on FDA Database →

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

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