G3 40 Radiopaque Bone Cement— 510(k) K193061

Substantially Equivalent

G21, S.R.L.

FDA 510(k) clearance K193061 for G3 40 Radiopaque Bone Cement, Substantially Equivalent on 2020-03-19. Applicant: G21, S.R.L..

Clearance details

Applicant: G21, S.R.L.
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2019-11-01
Decision date: 2020-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Possidonio, IT

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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.