MALLEOLAR SCREW— 510(k) K931686

Substantially Equivalent

Onyx Medical Corp.

FDA 510(k) clearance K931686 for MALLEOLAR SCREW, Substantially Equivalent on 1994-04-05. Applicant: Onyx Medical Corp..

Clearance details

Applicant: Onyx Medical Corp.
Product code: Code KTW
Advisory panel: Orthopedic
Date received: 1993-04-05
Decision date: 1994-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.