Vivorte, Inc.

FDA Regulatory Profile

Vivorte, Inc. appears in FDA public data with 1 recall, 4 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2024-2021, Class II) was initiated on September 9, 2018. Its most recent 510(k) clearance was granted on January 14, 2015.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2024-2021Class IIVivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model NumbeSeptember 9, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K143549Vivorte TrabexusJanuary 14, 2015
K143547Vivorte Trabexus EBJanuary 14, 2015
K130703VIVORTE BVFSeptember 12, 2013
K131133VIVORTE BVF LITEAugust 12, 2013