Medicon Epiplating System— 510(k) K241253

Name: FDA 510(k) clearance K241253
Creator: U.S. Food and Drug Administration
Published: 2024-12-12

Substantially Equivalent

Cmf Medicon Surgical, Inc.

FDA 510(k) clearance K241253 for Medicon Epiplating System, Substantially Equivalent on 2024-12-12. Applicant: Cmf Medicon Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Cmf Medicon Surgical, Inc.
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
Advisory panel: General, Plastic Surgery
Date received: 2024-05-03
Decision date: 2024-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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K161548 — Osseointegrated Fixtures2016-12-01
K090803 — HANSON MEDICAL FACIAL IMPLANTS2010-06-30
K090630 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)2009-06-02
K071018 — MONARCH NASAL IMPLANT2007-05-25
K041690 — MONARCH NASAL IMPLANT2005-02-11

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Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

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.