K241011
- 510(k) number
- K241011
- Device name
- Mako Total Knee Application
- Applicant
- Mako Surgical Corp. FL · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-06-11
- Date received
- 2024-04-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K241011.pdf
Official FDA record: K241011
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.