BioSphere MIS Putty (BioSphere MIS)— 510(k) K173301

Substantially Equivalent

Synergy Biomedical, LLC

FDA 510(k) clearance K173301 for BioSphere MIS Putty (BioSphere MIS), Substantially Equivalent on 2018-01-19. Applicant: Synergy Biomedical, LLC.

Clearance details

Applicant: Synergy Biomedical, LLC
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2017-10-17
Decision date: 2018-01-19
Decision: Substantially Equivalent
Clearance type: Special
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.