FDA-Device2014-06-25Class II
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Synthes, Inc.
Hazard
Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.
Sold states
Worldwide Distribution - USA (nationwide) and Canada.
Affected count
5,114,052
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1833-2014Don't want to check this manually?
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