FDA-Device2015-09-30Class II

3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.

OrthoPediatrics Corp
Hazard

The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.

Sold states
Domestic: TN, IA Foreign: England VA/DOD: None
Affected count
5
Manufactured in
2850 Frontier Dr, N/A, Warsaw, IN, United States
Products
3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2796-2015

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