SYNTEC OSTEO-PLATE AND SCREW FIXATION— 510(k) K092889

Substantially Equivalent

Syntec Scientific Corp.

FDA 510(k) clearance K092889 for SYNTEC OSTEO-PLATE AND SCREW FIXATION, Substantially Equivalent on 2010-06-25. Applicant: Syntec Scientific Corp..

Clearance details

Applicant: Syntec Scientific Corp.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2009-09-21
Decision date: 2010-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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.