KALIX II IMPLANT, MODEL 141 0XX WITH XX— 510(k) K053093

Name: FDA 510(k) clearance K053093
Creator: U.S. Food and Drug Administration
Published: 2005-12-07

Substantially Equivalent

New Deal, S.A.

FDA 510(k) clearance K053093 for KALIX II IMPLANT, MODEL 141 0XX WITH XX, Substantially Equivalent on 2005-12-07. Applicant: New Deal, S.A.. Device class: 2.

Clearance details

Applicant: New Deal, S.A.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2005-11-03
Decision date: 2005-12-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Planisboro, NJ, US

Download summary PDF View on FDA.gov ↗

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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.