NELSON RESURFACING HEAD— 510(k) K983452

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K983452 for NELSON RESURFACING HEAD, Substantially Equivalent on 1998-12-03. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code KXA
Advisory panel: Orthopedic
Date received: 1998-09-30
Decision date: 1998-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code KXA

product code KXA

Injury: 324
Total: 324

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.