Mediant Anterior Cervical Plating System— 510(k) K173935

Substantially Equivalent

Intelligent Implant Systems, LLC

FDA 510(k) clearance K173935 for Mediant Anterior Cervical Plating System, Substantially Equivalent on 2018-04-16. Applicant: Intelligent Implant Systems, LLC.

Clearance details

Applicant: Intelligent Implant Systems, LLC
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2017-12-26
Decision date: 2018-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, US

Download summary PDF View 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, 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.