Urbanek Device— 510(k) K170985

Substantially Equivalent

Tmj Services, LLC

FDA 510(k) clearance K170985 for Urbanek Device, Substantially Equivalent on 2017-09-25. Applicant: Tmj Services, LLC.

Clearance details

Applicant: Tmj Services, LLC
Product code: Code MQC
Advisory panel: Unknown
Date received: 2017-04-03
Decision date: 2017-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.