MAVERICK Mini External Fixation System— 510(k) K223112

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K223112 for MAVERICK Mini External Fixation System, Substantially Equivalent on 2022-12-08. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code JDW
Advisory panel: Orthopedic
Date received: 2022-10-03
Decision date: 2022-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cordova, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.