FINE GRAIN CAST COBALT CHROMIUM HIP STEMS— 510(k) K953925

Substantially Equivalent for Some Indications

Biomet, Inc.

FDA 510(k) clearance K953925 for FINE GRAIN CAST COBALT CHROMIUM HIP STEMS, Substantially Equivalent for Some Indications on 1996-01-31. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1995-08-18
Decision date: 1996-01-31
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.