KRONNER SACRAL PIN GUIDE— 510(k) K895172

Substantially Equivalent

Kronner Medical

FDA 510(k) clearance K895172 for KRONNER SACRAL PIN GUIDE, Substantially Equivalent on 1989-09-12. Applicant: Kronner Medical.

Clearance details

Applicant: Kronner Medical
Product code: Code LXH
Advisory panel: Orthopedic
Date received: 1989-08-10
Decision date: 1989-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseburg, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

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.