OSFERION— 510(k) K080065

Name: FDA 510(k) clearance K080065
Creator: U.S. Food and Drug Administration
Published: 2008-05-02

Substantially Equivalent

Olympus Terumo Biomaterials Corporation

FDA 510(k) clearance K080065 for OSFERION, Substantially Equivalent on 2008-05-02. Applicant: Olympus Terumo Biomaterials Corporation. Device class: 2.

Clearance details

Applicant: Olympus Terumo Biomaterials Corporation
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2008-01-10
Decision date: 2008-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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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.