Bone Solutions, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bone Solutions, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Mg OSTEOINJECT™, Mg OSTEOREVIVE™, Mg OSTEOCRETE™, Mg OSTEOINJECT™
8
Total
8
Cleared
0
Denied
Bone Solutions, Inc. has 8 FDA 510(k) cleared medical devices. Based in Santa Barbara, US.
Latest FDA clearance: Oct 2025. Active since 2009. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Bone Solutions, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by PaxMed International, LLC and Backroads Consulting.
FDA 510(k) Regulatory Record - Bone Solutions, Inc.
8 devices
Cleared
Oct 13, 2025
Mg OSTEOINJECT™
Orthopedic
150d
Cleared
Oct 18, 2024
Mg OSTEOREVIVE™, Mg OSTEOCRETE™
Orthopedic
70d
Cleared
Feb 05, 2024
Mg OSTEOINJECT™
Orthopedic
48d
Cleared
Jun 28, 2022
Mg OSTEOINJECT
Orthopedic
57d
Cleared
Jan 21, 2022
Osteorevive
Orthopedic
123d
Cleared
Feb 18, 2020
Mixing and Delivery System
General & Plastic Surgery
145d
Cleared
Sep 16, 2016
Bone Solutions Mixing and Delivery System
General Hospital
101d
Cleared
May 21, 2009
OSTEOCRETE BONE VOID FILLER
Orthopedic
773d