THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)— 510(k) K072231

Substantially Equivalent

Esm Technologies, LLC

FDA 510(k) clearance K072231 for THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE), Substantially Equivalent on 2007-12-26. Applicant: Esm Technologies, LLC.

Clearance details

Applicant: Esm Technologies, LLC
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2007-08-10
Decision date: 2007-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, 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.