WELLGRAFT PE I— 510(k) K072444

Substantially Equivalent

Gwowei Technology Co., Ltd.

FDA 510(k) clearance K072444 for WELLGRAFT PE I, Substantially Equivalent on 2008-04-04. Applicant: Gwowei Technology Co., Ltd..

Clearance details

Applicant
Gwowei Technology Co., Ltd.
Product code
Code MQV
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Flagstaff, AZ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MQV

product code MQV
Death
6
Injury
435
Total
441

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.