K051616

Substantially Equivalent

VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES

Applicant: Vanguard Medical Concepts, Inc.
Product code: KTT
Advisory panel: Orthopedic
Date received: 2005-06-17
Decision date: 2005-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakeland, FL, US

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.