AlloSource, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
37
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1562-2014Class IIAlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications asMarch 25, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K213046AceConnex Pre-Sutured FasciaJune 27, 2023
K170957ReConnex Pre-Sutured TendonMarch 20, 2018
K103036ALLOFUSE PLUSJanuary 10, 2011
K071849ALLOFUSE GEL AND PUTTYDecember 4, 2008