DeviceClearance

Product code LOD— Orthopedic

BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60

Classification name
Bone Cement
Device class
Class 2
Regulation
21 CFR 888.3027
Advisory panel
Orthopedic
Total cleared
72
First cleared
Most recent

Market context for product code LOD

FDA has cleared 72 devices under product code LOD between 2000 and 2026, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LOD

Adverse events under product code LOD

product code LOD
Death
44
Injury
3,004
Malfunction
895
Other
4
Total
3,947

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LOD

Data sourced from openFDA. This site is unofficial and independent of the FDA.