KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE— 510(k) K901234

Substantially Equivalent

Kirschner Medical Corp.

FDA 510(k) clearance K901234 for KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE, Substantially Equivalent on 1990-10-04. Applicant: Kirschner Medical Corp..

Clearance details

Applicant: Kirschner Medical Corp.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 1990-03-14
Decision date: 1990-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Timonium, MD, US

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.