Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED— 510(k) K040685

Substantially Equivalent

Osteoimplant Technology, Inc.

FDA 510(k) clearance K040685 for Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED, Substantially Equivalent on 2005-01-25. Applicant: Osteoimplant Technology, Inc..

Clearance details

Applicant: Osteoimplant Technology, Inc.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 2004-03-16
Decision date: 2005-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hunt Valley, MD, US

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.