OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail— 510(k) K231272

Substantially Equivalent

OSSIO , Ltd.

FDA 510(k) clearance K231272 for OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail, Substantially Equivalent on 2023-12-01. Applicant: OSSIO , Ltd..

Clearance details

Applicant: OSSIO , Ltd.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2023-05-02
Decision date: 2023-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

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.