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

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..

Clearance details

Applicant: New Deal, S.A.
Product code: Code HWC
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 ↗

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.