510(k) K023188— PRESS-FIT HEAD RESURFACING DEVICE

Substantially Equivalent

Biomet Orthopedics, Inc.

Clearance details

Applicant: Biomet Orthopedics, Inc.
Product code: Code KXA
Advisory panel: Orthopedic
Date received: 2002-09-24
Decision date: 2002-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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.