Cavetto-SA Cervical Cage System— 510(k) K173077

Substantially Equivalent

Neurostructures, Inc.

FDA 510(k) clearance K173077 for Cavetto-SA Cervical Cage System, Substantially Equivalent on 2018-02-23. Applicant: Neurostructures, Inc..

Clearance details

Applicant
Neurostructures, Inc.
Product code
Code OVE
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code OVE

product code OVE
Injury
293
Malfunction
710
Total
1,003

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.