MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS— 510(k) K013658

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K013658 for MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS, Substantially Equivalent on 2001-12-05. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2001-11-06
Decision date: 2001-12-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.