REPROCESSED EXTERNAL FIXATION DEVICE— 510(k) K012634

Substantially Equivalent

Alliance Medical, Inc.

FDA 510(k) clearance K012634 for REPROCESSED EXTERNAL FIXATION DEVICE, Substantially Equivalent on 2002-06-24. Applicant: Alliance Medical, Inc..

Clearance details

Applicant: Alliance Medical, Inc.
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.