CONCERT RADIOPAQUE BONE CEMENT— 510(k) K013755

Substantially Equivalent

Immedica, Inc.

FDA 510(k) clearance K013755 for CONCERT RADIOPAQUE BONE CEMENT, Substantially Equivalent on 2002-02-08. Applicant: Immedica, Inc..

Clearance details

Applicant: Immedica, Inc.
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2001-11-13
Decision date: 2002-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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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.