SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM— 510(k) K130044

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K130044 for SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 2013-04-05. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2013-01-08
Decision date: 2013-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.