BioSphere Flex— 510(k) K173424

Substantially Equivalent

Synergy Biomedical

FDA 510(k) clearance K173424 for BioSphere Flex, Substantially Equivalent on 2018-09-12. Applicant: Synergy Biomedical.

Clearance details

Applicant: Synergy Biomedical
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2017-11-01
Decision date: 2018-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Collegeville, PA, 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.