K250608
- 510(k) number
- K250608
- Device name
- Mako Total Knee Application (3.0); Hybrid Tip Pointer
- Applicant
- Mako Surgical Corp. FL · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-04-25
- Date received
- 2025-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250608.pdf
Official FDA record: K250608
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.