OGDEN ANCHOR-SMALL (TENTATIVE)— 510(k) K941029

Name: FDA 510(k) clearance K941029
Creator: U.S. Food and Drug Administration
Published: 1995-02-09

Substantially Equivalent

American Medical Electronics, Inc.

FDA 510(k) clearance K941029 for OGDEN ANCHOR-SMALL (TENTATIVE), Substantially Equivalent on 1995-02-09. Applicant: American Medical Electronics, Inc.. Device class: 2.

Clearance details

Applicant: American Medical Electronics, Inc.
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1994-03-07
Decision date: 1995-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.