BIOGENNIX RPC— 510(k) K093342

Substantially Equivalent

Biogennix, LLC

FDA 510(k) clearance K093342 for BIOGENNIX RPC, Substantially Equivalent on 2010-07-29. Applicant: Biogennix, LLC.

Clearance details

Applicant: Biogennix, LLC
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2009-10-26
Decision date: 2010-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, 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.