K152071

Substantially Equivalent

NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)

Applicant: Novabone Products, LLC
Product code: MQV
Advisory panel: Orthopedic
Date received: 2015-07-27
Decision date: 2015-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Alachua, FL, US

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.