ORTHOMIX— 510(k) K760636

Substantially Equivalent

Diemolding Corp.

FDA 510(k) clearance K760636 for ORTHOMIX, Substantially Equivalent on 1976-10-05. Applicant: Diemolding Corp..

Clearance details

Applicant
Diemolding Corp.
Product code
Code JDZ
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JDZ

product code JDZ
Malfunction
461
Total
461

Source: openFDA MAUDE database, through . 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.