ODI 7.0MM CANNULATED SCREW SYSTEM— 510(k) K030619

Name: FDA 510(k) clearance K030619
Creator: U.S. Food and Drug Administration
Published: 2003-04-01

Substantially Equivalent

Orthopedic Designs, Inc.

FDA 510(k) clearance K030619 for ODI 7.0MM CANNULATED SCREW SYSTEM, Substantially Equivalent on 2003-04-01. Applicant: Orthopedic Designs, Inc.. Device class: 2.

Clearance details

Applicant: Orthopedic Designs, Inc.
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2003-02-27
Decision date: 2003-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.