Osseofuse International, Inc.

FDA Regulatory Profile

Osseofuse International, Inc. appears in FDA public data with 0 recalls, 2 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on October 10, 2025.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243078HexaPLUS S OneDrill Implant SystemOctober 10, 2025
K181157Conical Plus Implant SystemMay 24, 2019