510(k) K190652— OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant

Substantially Equivalent

OSSIO , Ltd.

Clearance details

Applicant: OSSIO , Ltd.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2019-03-13
Decision date: 2020-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.