Ultima HA Coated Half Pins and Wire— 510(k) K163487

Name: FDA 510(k) clearance K163487
Creator: U.S. Food and Drug Administration
Published: 2017-02-13

Substantially Equivalent

Vilex IN Tennessee, Inc.

FDA 510(k) clearance K163487 for Ultima HA Coated Half Pins and Wire, Substantially Equivalent on 2017-02-13. Applicant: Vilex IN Tennessee, Inc.. Device class: 2.

Clearance details

Applicant: Vilex IN Tennessee, Inc.
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2016-12-12
Decision date: 2017-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcminnville, TN, 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.