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FDA 510(k)

MedCAD AccuPlan Orthopedics System

K-Number: K223421 · 2023-09-20

ApplicantMedcad
Decision Date2023-09-20
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MedCAD AccuPlan Orthopedics System is a medical device manufactured by Medcad. It received FDA 510(k) clearance on 2023-09-20 under approval number K223421. 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 AccuPlan Orthopedics System?

MedCAD AccuPlan Orthopedics System is a medical device that received FDA 510(k) clearance on 2023-09-20. It is manufactured by Medcad. The 510(k) number is K223421.

When was MedCAD AccuPlan Orthopedics System approved by the FDA?

MedCAD AccuPlan Orthopedics System received FDA 510(k) clearance on 2023-09-20, under approval number K223421.

What company makes MedCAD AccuPlan Orthopedics System?

MedCAD AccuPlan Orthopedics System is manufactured by Medcad.

What is the FDA product code for MedCAD AccuPlan Orthopedics System?

The FDA product code for MedCAD AccuPlan Orthopedics System is PBF.

Related Clinical Trials

NCT07254351 Analysis of the Biomechanical Impact of Lower Limb Length Inequality in PEDiatrics RECRUITING

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Related Devices (Code: PBF)

K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV K190044VSP Orthopedics System3D Systems, Inc. K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. K2122373D-Cut3D-Side S.A. K211244VSP® Orthopedics System3D Systems K211614CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, 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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