ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)— 510(k) K925345

Substantially Equivalent for Some Indications

Biomet, Inc.

FDA 510(k) clearance K925345 for ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM), Substantially Equivalent for Some Indications on 1994-03-10. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1992-10-22
Decision date: 1994-03-10
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, 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.