OSTEOPAL V— 510(k) K050085

Name: FDA 510(k) clearance K050085
Creator: U.S. Food and Drug Administration
Published: 2005-09-14

Substantially Equivalent

Heraeus Kulzer,GmbH

FDA 510(k) clearance K050085 for OSTEOPAL V, Substantially Equivalent on 2005-09-14. Applicant: Heraeus Kulzer,GmbH. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer,GmbH
Product code: Code LOD
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2005-01-13
Decision date: 2005-09-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hanau, DE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

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.