EXCIA TOTAL HIP SYSTEM— 510(k) K042344

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K042344 for EXCIA TOTAL HIP SYSTEM, Substantially Equivalent on 2005-03-16. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 2004-08-30
Decision date: 2005-03-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Center Valley, PA, 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.