AESCULAP ORTHOPILOT 2 THA V 2.0— 510(k) K050752

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K050752 for AESCULAP ORTHOPILOT 2 THA V 2.0, Substantially Equivalent on 2005-04-27. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2005-03-23
Decision date: 2005-04-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

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Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.