VERTEX Nitinol Staple System— 510(k) K182943

Substantially Equivalent

Nvision Biomedical Technologies, LLC

FDA 510(k) clearance K182943 for VERTEX Nitinol Staple System, Substantially Equivalent on 2019-04-04. Applicant: Nvision Biomedical Technologies, LLC.

Clearance details

Applicant: Nvision Biomedical Technologies, LLC
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2018-10-23
Decision date: 2019-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.