K242121
- 510(k) number
- K242121
- Device name
- mBôs (Monogram mBôs TKA System)
- Applicant
- Monogram Orthopaedics, Inc. TX · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-03-14
- Date received
- 2024-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242121.pdf
Official FDA record: K242121
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.