KENS INTERNAL FIXATION SYSTEM— 510(k) K090786

Name: FDA 510(k) clearance K090786
Creator: U.S. Food and Drug Administration
Published: 2009-06-18

Substantially Equivalent

Kens Finemedtech Sdn. Bhd

FDA 510(k) clearance K090786 for KENS INTERNAL FIXATION SYSTEM, Substantially Equivalent on 2009-06-18. Applicant: Kens Finemedtech Sdn. Bhd. Device class: 2.

Clearance details

Applicant: Kens Finemedtech Sdn. Bhd
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2009-03-23
Decision date: 2009-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bayan Lepas, MY

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.