BonVie+— 510(k) K250346

Substantially Equivalent

Elute, Inc.

FDA 510(k) clearance K250346 for BonVie+, Substantially Equivalent on 2025-02-26. Applicant: Elute, Inc..

Clearance details

Applicant: Elute, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2025-02-06
Decision date: 2025-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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.