K242864
- 510(k) number
- K242864
- Device name
- ROSA® Knee System
- Applicant
- Orthosoft Inc. (d/b/a) Zimmer CAS CA
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-10-18
- Date received
- 2024-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242864.pdf
Official FDA record: K242864
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.