K880998

Substantially Equivalent

STERNUM SPREADER, PEDIATRIC

Applicant: T. Korossurgical Instruments Corp.
Product code: GAD
Advisory panel: General, Plastic Surgery
Date received: 1988-03-08
Decision date: 1988-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moorepark, CA, US

Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.