K132735

Substantially Equivalent

AXIA RADIAL HEAD SYSTEM

Applicant: Imds (Innovative MEdical Device Systems) - Leis ME
Product code: KWI
Advisory panel: Orthopedic
Date received: 2013-09-03
Decision date: 2014-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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.