AAP BONE PLATES AND SCREW IMPLANTS— 510(k) K072411

Substantially Equivalent

Aap Implantate AG

FDA 510(k) clearance K072411 for AAP BONE PLATES AND SCREW IMPLANTS, Substantially Equivalent on 2008-03-20. Applicant: Aap Implantate AG.

Clearance details

Applicant
Aap Implantate AG
Product code
Code HRS
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Berlin, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code HRS

product code HRS
Death
27
Injury
10,340
Malfunction
3,328
Total
13,695

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.