CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE— 510(k) K081374

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K081374 for CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE, Substantially Equivalent on 2008-09-09. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2008-05-16
Decision date: 2008-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.