VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES— 510(k) K132820

Substantially Equivalent

Vilex, Inc.

FDA 510(k) clearance K132820 for VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES, Substantially Equivalent on 2014-07-23. Applicant: Vilex, Inc..

Clearance details

Applicant: Vilex, Inc.
Product code: Code JDW
Advisory panel: Orthopedic
Date received: 2013-09-09
Decision date: 2014-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood Ranch, FL, US

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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.