SMV Scientific K-Wire and Pins— 510(k) K182171

Name: FDA 510(k) clearance K182171
Creator: U.S. Food and Drug Administration
Published: 2018-10-25

Substantially Equivalent

Summit Medventures

FDA 510(k) clearance K182171 for SMV Scientific K-Wire and Pins, Substantially Equivalent on 2018-10-25. Applicant: Summit Medventures. Device class: 2.

Clearance details

Applicant: Summit Medventures
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2018-08-10
Decision date: 2018-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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.