CMC CABLE FIX— 510(k) K111032

Name: FDA 510(k) clearance K111032
Creator: U.S. Food and Drug Administration
Published: 2011-08-31

Substantially Equivalent

Instratek, Inc.

FDA 510(k) clearance K111032 for CMC CABLE FIX, Substantially Equivalent on 2011-08-31. Applicant: Instratek, Inc.. Device class: 2.

Clearance details

Applicant: Instratek, Inc.
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2011-04-13
Decision date: 2011-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.