FDA 510(k) clearance · back to tracker

ROSA® Shoulder System

Orthosoft Inc. (d/b/a) Zimmer CAS cleared K260582 on 2026-05-21, decision: substantially equivalent

K-number

K260582

Sponsor

Orthosoft Inc. (d/b/a) Zimmer CAS

Device

ROSA® Shoulder System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-21

Product code

OLO

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.4560

Official FDA record

Open K260582on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.