INTERFACE BONE VOID FILLER— 510(k) K112857

Substantially Equivalent

Biostructures, LLC

FDA 510(k) clearance K112857 for INTERFACE BONE VOID FILLER, Substantially Equivalent on 2011-12-13. Applicant: Biostructures, LLC.

Clearance details

Applicant: Biostructures, LLC
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2011-09-30
Decision date: 2011-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.