FDA-Device2017-11-22Class II
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgi
Zimmer Biomet, Inc.
Hazard
Observed instability of the device.
Sold states
Nationwide Distribution to AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, NY, OH, PA, and TX
Affected count
53 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0099-2018Don't want to check this manually?
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