K140844

Substantially Equivalent

BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC

Applicant: Synergy Biomedical, Inc.
Product code: MQV
Advisory panel: Orthopedic
Date received: 2014-04-02
Decision date: 2014-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.