G3A 40 Bone Cement— 510(k) K181282

Substantially Equivalent

G21, S.R.L.

FDA 510(k) clearance K181282 for G3A 40 Bone Cement, Substantially Equivalent on 2019-01-09. Applicant: G21, S.R.L..

Clearance details

Applicant: G21, S.R.L.
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2018-05-15
Decision date: 2019-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Possidomio, IT

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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