NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System— 510(k) K150561

Substantially Equivalent

Narang Medical Limited

FDA 510(k) clearance K150561 for NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System, Substantially Equivalent on 2015-11-25. Applicant: Narang Medical Limited.

Clearance details

Applicant
Narang Medical Limited
Product code
Code HRS
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New Delhi, IN
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.