ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM— 510(k) K926395

Substantially Equivalent for Some Indications

Depuy, Inc.

FDA 510(k) clearance K926395 for ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM, Substantially Equivalent for Some Indications on 1994-03-10. Applicant: Depuy, Inc..

Clearance details

Applicant: Depuy, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1992-12-21
Decision date: 1994-03-10
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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.