OGDEN ANCHOR (MODIFICATION)— 510(k) K935167

Substantially Equivalent for Some Indications

American Medical Electronics, Inc.

FDA 510(k) clearance K935167 for OGDEN ANCHOR (MODIFICATION), Substantially Equivalent for Some Indications on 1994-07-12. Applicant: American Medical Electronics, Inc..

Clearance details

Applicant: American Medical Electronics, Inc.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 1993-10-27
Decision date: 1994-07-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Richardson, TX, US

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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.