BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC— 510(k) K140844

Substantially Equivalent

Synergy Biomedical, Inc.

FDA 510(k) clearance K140844 for BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC, Substantially Equivalent on 2014-07-16. Applicant: Synergy Biomedical, Inc..

Clearance details

Applicant: Synergy Biomedical, Inc.
Product code: 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

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.