NEWDEAL K WIRE— 510(k) K022599

Name: FDA 510(k) clearance K022599
Creator: U.S. Food and Drug Administration
Published: 2002-10-30

Substantially Equivalent

New Deal, S.A.

FDA 510(k) clearance K022599 for NEWDEAL K WIRE, Substantially Equivalent on 2002-10-30. Applicant: New Deal, S.A.. Device class: 2.

Clearance details

Applicant: New Deal, S.A.
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2002-08-05
Decision date: 2002-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.