FDA 510(k)

ROSA® Knee System

K-Number: K230243 · 2023-03-29

Decision Date2023-03-29

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ROSA® Knee System is a medical device manufactured by Orthosoft D/B/A Zimmer Cas. It received FDA 510(k) clearance on 2023-03-29 under approval number K230243. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSA® Knee System?

ROSA® Knee System is a medical device that received FDA 510(k) clearance on 2023-03-29. It is manufactured by Orthosoft D/B/A Zimmer Cas. The 510(k) number is K230243.

When was ROSA® Knee System approved by the FDA?

ROSA® Knee System received FDA 510(k) clearance on 2023-03-29, under approval number K230243.

What company makes ROSA® Knee System?

ROSA® Knee System is manufactured by Orthosoft D/B/A Zimmer Cas.

What is the FDA product code for ROSA® Knee System?

The FDA product code for ROSA® Knee System is OLO.

Other Devices by Orthosoft D/B/A Zimmer Cas

K210998ROSA Hip System K210653ONE Planner Hip K210121ROSA Partial Knee System K221928ROSA® Knee System K213033iASSIST Knee System K232533ROSA Partial Knee System

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Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.