K260582
- 510(k) number
- K260582
- Device name
- ROSA® Shoulder System
- Applicant
- Orthosoft Inc. (d/b/a) Zimmer CAS CA
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-05-21
- Date received
- 2026-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260582.pdf
Official FDA record: K260582
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.