510(k) clearance
Spine & Trauma Navigation
Brainlab AG · 11 June 2019 · K191285
- Decision
- Cleared: the FDA found it substantially equivalent to a device already on the market
- Decision date
- 11 June 2019
- Application received
- 13 May 2019
- Company
- Brainlab AG
- 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.