510(k) clearance
Mako Total Hip Application
Mako Surgical Corp. · 2 Feb 2020 · K193128
- Decision
- Cleared: the FDA found it substantially equivalent to a device already on the market
- Decision date
- 2 Feb 2020
- Application received
- 12 Nov 2019
- Company
- Mako Surgical Corp.
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
What it means
A 510(k) clearance means the FDA agreed the device is as safe and effective as one already on the market, so it may be sold in the US. It is not an approval and not a finding that it works better than surgery without a robot. See FDA clearance, explained.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.