STERNOTOMY CABLE, SONGER CABLE SYSTEM— 510(k) K903676

Substantially Equivalent

Danek Medical, Inc.

FDA 510(k) clearance K903676 for STERNOTOMY CABLE, SONGER CABLE SYSTEM, Substantially Equivalent on 1990-09-10. Applicant: Danek Medical, Inc..

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 1990-08-13
Decision date: 1990-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.