Woven Orthopedic Technologies

FDA Regulatory Profile

Woven Orthopedic Technologies appears in FDA public data with 0 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Jul 23, 2025 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Oct 26, 2023.

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Summary

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

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 23, 2025Stamford, CTDevicesNo Action Indicated (NAI)3017505709

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K233223OGmend® Implant Enhancement SystemOct 26, 2023
K223075Ogmend® Implant Enhancement SystemFeb 27, 2023
DEN180065OGmend Implant SystemMay 1, 2020