K233199
- 510(k) number
- K233199
- Device name
- ROSA® Shoulder System
- Applicant
- Orthosoft Inc (D/B/A Zimmer Cas) CA
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-02-21
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K233199.pdf
Official FDA record: K233199
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.