FDA-Device2017-04-19Class II
MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebr
Zimmer Biomet, Inc.
Hazard
Unapproved change made by the supplier.
Sold states
Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.
Affected count
1
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1755-2017Don't want to check this manually?
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