NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE— 510(k) K140946

Substantially Equivalent

Novabone Products, LLC

FDA 510(k) clearance K140946 for NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE, Substantially Equivalent on 2014-08-22. Applicant: Novabone Products, LLC.

Clearance details

Applicant: Novabone Products, LLC
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2014-04-14
Decision date: 2014-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, 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.