VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES— 510(k) K031687

Substantially Equivalent

Vanguard Medical Concepts, Inc.

FDA 510(k) clearance K031687 for VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES, Substantially Equivalent on 2004-04-30. Applicant: Vanguard Medical Concepts, Inc..

Clearance details

Applicant: Vanguard Medical Concepts, Inc.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2003-06-02
Decision date: 2004-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakeland, FL, US

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.