O-Genesis Graft Delivery System— 510(k) K200606

Substantially Equivalent

Orthofix, Inc.

FDA 510(k) clearance K200606 for O-Genesis Graft Delivery System, Substantially Equivalent on 2020-05-01. Applicant: Orthofix, Inc..

Clearance details

Applicant: Orthofix, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2020-03-09
Decision date: 2020-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisville, TX, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.