VIVORTE BVF LITE— 510(k) K131133

Substantially Equivalent

Vivorte, Inc.

FDA 510(k) clearance K131133 for VIVORTE BVF LITE, Substantially Equivalent on 2013-08-12. Applicant: Vivorte, Inc..

Clearance details

Applicant: Vivorte, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2013-04-23
Decision date: 2013-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Wayne, IN, US

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Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.