ORION BLADE PLATE FOR TIBIAL OSTEOTOMY— 510(k) K901272

Substantially Equivalent

Med-Tek Corp.

FDA 510(k) clearance K901272 for ORION BLADE PLATE FOR TIBIAL OSTEOTOMY, Substantially Equivalent on 1990-04-23. Applicant: Med-Tek Corp..

Clearance details

Applicant: Med-Tek Corp.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 1990-03-19
Decision date: 1990-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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.