Dall-Miles® Cable System— 510(k) K202016

Substantially Equivalent

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

FDA 510(k) clearance K202016 for Dall-Miles® Cable System, Substantially Equivalent on 2020-10-16. Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

Clearance details

Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2020-07-21
Decision date: 2020-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.