FDA-Device2012-08-01Class II
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
OrthoPediatrics Corp
Hazard
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Sold states
Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
Affected count
15 devices
Manufactured in
2850 Frontier Dr, Warsaw, IN, United States
Products
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2057-2012Don't want to check this manually?
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