B-BOP PLATE— 510(k) K052152

Substantially Equivalent

New Deal, S.A.

FDA 510(k) clearance K052152 for B-BOP PLATE, Substantially Equivalent on 2005-09-13. Applicant: New Deal, S.A..

Clearance details

Applicant: New Deal, S.A.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2005-08-08
Decision date: 2005-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planisboro, NJ, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.