OMEGA II MODULAR TOTAL HIP SYSTEM— 510(k) K000817

Substantially Equivalent

Osteoimplant Technology, Inc.

FDA 510(k) clearance K000817 for OMEGA II MODULAR TOTAL HIP SYSTEM, Substantially Equivalent on 2000-06-08. Applicant: Osteoimplant Technology, Inc..

Clearance details

Applicant: Osteoimplant Technology, Inc.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2000-03-13
Decision date: 2000-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hunt Valley, MD, US

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Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.