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FDA 510(k)

ROSA® Shoulder System

K-Number: K260582 · 2026-05-21

ApplicantOrthosoft Inc. (d/b/a) Zimmer CAS
Decision Date2026-05-21
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA® Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft Inc. (d/b/a) Zimmer CAS. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K260582. 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® Shoulder System?

ROSA® Shoulder System is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Orthosoft Inc. (d/b/a) Zimmer CAS. The 510(k) number is K260582.

When did ROSA® Shoulder System receive FDA 510(k) clearance?

ROSA® Shoulder System received FDA 510(k) clearance on 2026-05-21, under 510(k) number K260582.

Who is the listed applicant for ROSA® Shoulder System?

The FDA 510(k) record lists Orthosoft Inc. (d/b/a) Zimmer CAS as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Orthosoft Inc. (d/b/a) Zimmer CAS as applicant

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Related Devices (Code: OLO)

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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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