GLADIATOR BIPOLAR SYSTEM— 510(k) K062693

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K062693 for GLADIATOR BIPOLAR SYSTEM, Substantially Equivalent on 2006-09-29. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2006-09-11
Decision date: 2006-09-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.