HEMI IMPLANT; MINI HEMI IMPLANT— 510(k) K102401

Name: FDA 510(k) clearance K102401
Creator: U.S. Food and Drug Administration
Published: 2011-07-20

Substantially Equivalent

Vilex, Inc.

FDA 510(k) clearance K102401 for HEMI IMPLANT; MINI HEMI IMPLANT, Substantially Equivalent on 2011-07-20. Applicant: Vilex, Inc.. Device class: 2.

Clearance details

Applicant: Vilex, Inc.
Product code: Code KWD
Device class: Class 2
Regulation: 21 CFR 888.3730
Advisory panel: Orthopedic
Date received: 2010-08-24
Decision date: 2011-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcminnville, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWD

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K250074 — HYALEX® MTP Hemiarthroplasty Implant2026-04-03
K240268 — Accu-Joint Hemi Implant2024-02-29
K221220 — Montross Extremity Medical Hemi Implant System2023-04-19
K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant2022-11-22
K201393 — restor3d MTP Implant2022-05-25

More clearances from Vilex, Inc.

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K132820 — VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES2014-07-23
K112837 — VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)2012-10-09
K102413 — FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL2011-11-14
K070052 — MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION2007-03-28
K052196 — VILEX X-FIX2005-11-22

Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.