FDA Product Code LOD: Bone Cement
Leading manufacturers include Osteoremedies, LLC, Tecres S.P.A. and Heraeus Medical GmbH.
FDA 510(k) Cleared Bone Cement Devices (Product Code LOD)
About Product Code LOD - Regulatory Context
510(k) Submission Activity
72 total 510(k) submissions under product code LOD since 2000, with 72 receiving FDA clearance (average review time: 167 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under LOD have taken an average of 105 days to reach a decision - down from 169 days historically, suggesting improved FDA processing for this classification.
LOD devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →