MODIFICATION TO THE BOLD SCREW— 510(k) K011262

Substantially Equivalent

New Deal, S.A.

FDA 510(k) clearance K011262 for MODIFICATION TO THE BOLD SCREW, Substantially Equivalent on 2001-06-15. Applicant: New Deal, S.A..

Clearance details

Applicant: New Deal, S.A.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2001-04-25
Decision date: 2001-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.