Bone Solutions, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™October 13, 2025
K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™October 18, 2024
K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™February 5, 2024
K221256Mg OSTEOINJECTJune 28, 2022
K212991OsteoreviveJanuary 21, 2022
K192674Mixing and Delivery SystemFebruary 18, 2020
K161568Bone Solutions Mixing and Delivery SystemSeptember 16, 2016
K071004OSTEOCRETE BONE VOID FILLERMay 21, 2009