METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM— 510(k) K081973

Substantially Equivalent

Aesculap Implant Systems, Inc.

FDA 510(k) clearance K081973 for METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM, Substantially Equivalent on 2008-08-07. Applicant: Aesculap Implant Systems, Inc..

Clearance details

Applicant: Aesculap Implant Systems, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2008-07-10
Decision date: 2008-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

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Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.