Impress SFS System— 510(k) K173910

Substantially Equivalent

Cable Fix Medical, LLC

FDA 510(k) clearance K173910 for Impress SFS System, Substantially Equivalent on 2018-09-14. Applicant: Cable Fix Medical, LLC.

Clearance details

Applicant: Cable Fix Medical, LLC
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2017-12-22
Decision date: 2018-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hernando, MS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.