SIGNAFUSE Bioactive Bone Graft— 510(k) K193513

Substantially Equivalent

Bioventus

FDA 510(k) clearance K193513 for SIGNAFUSE Bioactive Bone Graft, Substantially Equivalent on 2020-06-18. Applicant: Bioventus.

Clearance details

Applicant: Bioventus
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2019-12-19
Decision date: 2020-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, 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.