FDA-Device2017-11-29Class II
ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
Zimmer Biomet, Inc.
Hazard
Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
Sold states
Worldwide Distribution - US (DC) and Internationally to Australia and France.
Affected count
3 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0105-2018Don't want to check this manually?
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