Syntec Non-Sterile Steinmann Pins System— 510(k) K200933

Name: FDA 510(k) clearance K200933
Creator: U.S. Food and Drug Administration
Published: 2020-05-05

Substantially Equivalent

Syntec Scientific Corporation

FDA 510(k) clearance K200933 for Syntec Non-Sterile Steinmann Pins System, Substantially Equivalent on 2020-05-05. Applicant: Syntec Scientific Corporation. Device class: 2.

Clearance details

Applicant: Syntec Scientific Corporation
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2020-04-07
Decision date: 2020-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Chang Hua, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.