SYNTHES STERNAL ZIPFIX SYSTEM— 510(k) K110789

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K110789 for SYNTHES STERNAL ZIPFIX SYSTEM, Substantially Equivalent on 2011-07-28. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2011-03-22
Decision date: 2011-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, 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.