AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE— 510(k) K131459

Name: FDA 510(k) clearance K131459
Creator: U.S. Food and Drug Administration
Published: 2013-10-17

Substantially Equivalent

Aap Implantate AG

FDA 510(k) clearance K131459 for AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE, Substantially Equivalent on 2013-10-17. Applicant: Aap Implantate AG. Device class: 2.

Clearance details

Applicant: Aap Implantate AG
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2013-05-20
Decision date: 2013-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

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.