AMERICANA HIP PROTHESIS— 510(k) K922682

Substantially Equivalent

Osteo Technology, Inc.

FDA 510(k) clearance K922682 for AMERICANA HIP PROTHESIS, Substantially Equivalent on 1993-03-16. Applicant: Osteo Technology, Inc..

Clearance details

Applicant: Osteo Technology, Inc.
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1992-06-04
Decision date: 1993-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Timonium, MD, US

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Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.