ORTHOMIX— 510(k) K760636

Name: FDA 510(k) clearance K760636
Creator: U.S. Food and Drug Administration
Published: 1976-10-05

Substantially Equivalent

Diemolding Corp.

FDA 510(k) clearance K760636 for ORTHOMIX, Substantially Equivalent on 1976-10-05. Applicant: Diemolding Corp.. Device class: 1.

Clearance details

Applicant: Diemolding Corp.
Product code: Code JDZ
Device class: Class 1
Regulation: 21 CFR 888.4210
Advisory panel: Orthopedic
Date received: 1976-09-13
Decision date: 1976-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K902713 — ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS1990-07-25
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Adverse events under product code JDZ

product code JDZ

Malfunction: 461
Total: 461

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.