METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD— 510(k) K082146

Substantially Equivalent

Aesculap Implant Systems, Inc.

FDA 510(k) clearance K082146 for METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD, Substantially Equivalent on 2008-09-09. Applicant: Aesculap Implant Systems, Inc..

Clearance details

Applicant: Aesculap Implant Systems, Inc.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 2008-07-30
Decision date: 2008-09-09
Decision: Substantially Equivalent
Clearance type: Special
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.