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

Name: FDA 510(k) clearance K132820
Creator: U.S. Food and Drug Administration
Published: 2014-07-23

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.. Device class: 2.

Clearance details

Applicant: Vilex, Inc.
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2013-09-09
Decision date: 2014-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood Ranch, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vilex, Inc.

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K112837 — VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)2012-10-09
K102413 — FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL2011-11-14
K102401 — HEMI IMPLANT; MINI HEMI IMPLANT2011-07-20
K070052 — MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION2007-03-28
K052196 — VILEX X-FIX2005-11-22

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.