HANSEN-STREET TYPE INTRAMEDULLARY NAIL— 510(k) K905348

Name: FDA 510(k) clearance K905348
Creator: U.S. Food and Drug Administration
Published: 1990-12-11

Substantially Equivalent

O'Tec Corp.

FDA 510(k) clearance K905348 for HANSEN-STREET TYPE INTRAMEDULLARY NAIL, Substantially Equivalent on 1990-12-11. Applicant: O'Tec Corp.. Device class: 2.

Clearance details

Applicant: O'Tec Corp.
Product code: Code KTW
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1990-11-28
Decision date: 1990-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.