INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM— 510(k) K063020

Substantially Equivalent

Intai Technology, Inc.

FDA 510(k) clearance K063020 for INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM, Substantially Equivalent on 2006-12-14. Applicant: Intai Technology, Inc..

Clearance details

Applicant: Intai Technology, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2006-10-02
Decision date: 2006-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, CA, US

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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.