OSFERION— 510(k) K061499

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K061499 for OSFERION, Substantially Equivalent on 2007-01-26. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2006-05-31
Decision date: 2007-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

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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.