BIO 1-KIT BIOSORB FILLED CARTRIDGE— 510(k) K061022

Substantially Equivalent

Science For Biomaterials

FDA 510(k) clearance K061022 for BIO 1-KIT BIOSORB FILLED CARTRIDGE, Substantially Equivalent on 2006-05-24. Applicant: Science For Biomaterials.

Clearance details

Applicant: Science For Biomaterials
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2006-04-13
Decision date: 2006-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lourdes, FR

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.