KRONNER SPHERICAL CUTTERS— 510(k) K894228

Substantially Equivalent

Kronner Medical

FDA 510(k) clearance K894228 for KRONNER SPHERICAL CUTTERS, Substantially Equivalent on 1990-07-23. Applicant: Kronner Medical.

Clearance details

Applicant: Kronner Medical
Product code: Code HWT
Advisory panel: Orthopedic
Date received: 1989-06-19
Decision date: 1990-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseburg, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWT

product code HWT

Injury: 218
Malfunction: 12,907
Total: 13,125

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.