FACIAL RECONSTRUCTIVE MESH (FRM)— 510(k) K063154

Name: FDA 510(k) clearance K063154
Creator: U.S. Food and Drug Administration
Published: 2007-07-10

Substantially Equivalent

Evera Medical, Inc.

FDA 510(k) clearance K063154 for FACIAL RECONSTRUCTIVE MESH (FRM), Substantially Equivalent on 2007-07-10. Applicant: Evera Medical, Inc.. Device class: 2.

Clearance details

Applicant: Evera Medical, Inc.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2006-10-16
Decision date: 2007-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTL

view all

K253956 — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)2026-05-21
K253125 — Parietene Flat Sheet Mesh2025-10-24
K251955 — Onflex Mesh2025-07-24
K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped2025-06-12
K250869 — Parietene Macroporous Mesh (PPM5050 )2025-04-23

More clearances from Evera Medical, Inc.

view all

K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II2009-03-12

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.