NEXUS ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K131520

Substantially Equivalent

Core-Nexus

FDA 510(k) clearance K131520 for NEXUS ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2013-07-11. Applicant: Core-Nexus.

Clearance details

Applicant
Core-Nexus
Product code
Code KWQ
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Encino, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ
Death
8
Injury
1,212
Malfunction
1,233
Total
2,453

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.