ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2941-2024Class IIFRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM SystemJuly 4, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K241983Fassier-Duval Telescoping IM SystemFebruary 21, 2025