DeviceClearance

SECURIAN TISSUE REINFORCEMENT MATRIX— 510(k) K083823

Substantially Equivalent

Xylos Corporation

FDA 510(k) clearance K083823 for SECURIAN TISSUE REINFORCEMENT MATRIX, Substantially Equivalent on 2009-03-18. Applicant: Xylos Corporation.

Clearance details

Applicant
Xylos Corporation
Product code
Code FTM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Langhorne, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FTM

product code FTM
Death
17
Injury
2,174
Total
2,191

Source: openFDA MAUDE database, through . 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.