REPROCESSED EBI EXTERNAL FIXATION DEVICES— 510(k) K012645

Substantially Equivalent

Alliance Medical Corp.

FDA 510(k) clearance K012645 for REPROCESSED EBI EXTERNAL FIXATION DEVICES, Substantially Equivalent on 2002-06-24. Applicant: Alliance Medical Corp..

Clearance details

Applicant: Alliance Medical Corp.
Product code: Code KTW
Advisory panel: Orthopedic
Date received: 2001-08-13
Decision date: 2002-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.