SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty— 510(k) K233490

Substantially Equivalent

Bioventus, LLC

FDA 510(k) clearance K233490 for SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty, Substantially Equivalent on 2023-12-05. Applicant: Bioventus, LLC.

Clearance details

Applicant: Bioventus, LLC
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2023-10-27
Decision date: 2023-12-05
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.