ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER— 510(k) K013989

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K013989 for ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER, Substantially Equivalent on 2001-12-19. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2001-12-04
Decision date: 2001-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, 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.