MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM— 510(k) K050457

Substantially Equivalent

Merete Medical GmbH

FDA 510(k) clearance K050457 for MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM, Substantially Equivalent on 2005-03-14. Applicant: Merete Medical GmbH.

Clearance details

Applicant
Merete Medical GmbH
Product code
Code KTT
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York, NY, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KTT

product code KTT
Death
11
Injury
3,097
Malfunction
1,261
Total
4,369

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.