510(k) K063017— AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM

Substantially Equivalent

Aesculap, Inc.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2006-10-02
Decision date: 2006-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

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.