PANTA NAIL (DIA. 10MM), PANTA NAIL XL— 510(k) K091788

Substantially Equivalent

Newdeal Sas

FDA 510(k) clearance K091788 for PANTA NAIL (DIA. 10MM), PANTA NAIL XL, Substantially Equivalent on 2009-07-29. Applicant: Newdeal Sas.

Clearance details

Applicant: Newdeal Sas
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2009-06-17
Decision date: 2009-07-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Planisboro, NJ, US

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Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.