K251314
- 510(k) number
- K251314
- Device name
- Rosa® Knee System
- Applicant
- Orthosoft Inc. (d/b/a) Zimmer CAS CA
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-11-13
- Date received
- 2025-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K251314.pdf
Official FDA record: K251314
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.