FRAGMENT PLATE SYSTEM— 510(k) K061748

Name: FDA 510(k) clearance K061748
Creator: U.S. Food and Drug Administration
Published: 2006-07-17

Substantially Equivalent

Hand Innovations, LLC

FDA 510(k) clearance K061748 for FRAGMENT PLATE SYSTEM, Substantially Equivalent on 2006-07-17. Applicant: Hand Innovations, LLC. Device class: 2.

Clearance details

Applicant: Hand Innovations, LLC
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2006-06-21
Decision date: 2006-07-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.