NEOSTEO

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2236-2021Class IICannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedNovember 3, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K212545FlexitSystem Knee osteotomy systemFebruary 11, 2022
K192447Superelastic StapleFebruary 28, 2020
K191424Interphalangeal Joint Fusion Device RangeAugust 28, 2019
K153182SELF- COMPRESSIVE SCREWNovember 25, 2015
K150772Snap-Off Self-Compressive ScrewMay 8, 2015
K131471SELF-COMPRESSIVE SCREWAugust 28, 2013