OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM— 510(k) K040225

Substantially Equivalent

Osteoimplant Technology, Inc.

FDA 510(k) clearance K040225 for OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM, Substantially Equivalent on 2004-05-06. Applicant: Osteoimplant Technology, Inc..

Clearance details

Applicant: Osteoimplant Technology, Inc.
Product code: Code KWZ
Advisory panel: Orthopedic
Date received: 2004-02-02
Decision date: 2004-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hunt Valley, MD, US

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Adverse events under product code KWZ

product code KWZ

Injury: 993
Total: 993

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.