K260222
- 510(k) number
- K260222
- Device name
- Mako Total Knee Application
- Applicant
- Mako Surgical Corp. FL · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-02-25
- Date received
- 2026-01-26
- 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: K260222.pdf
Official FDA record: K260222
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.