SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079— 510(k) K051848

Substantially Equivalent

Davol Inc., Sub. C. R. Bard, Inc.

FDA 510(k) clearance K051848 for SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079, Substantially Equivalent on 2005-08-11. Applicant: Davol Inc., Sub. C. R. Bard, Inc..

Clearance details

Applicant: Davol Inc., Sub. C. R. Bard, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2005-07-07
Decision date: 2005-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canston, RI, US

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.