510(k) K201219— Biocore9 Femoral Head Resurfacing Component

Substantially Equivalent

Biocore9, LLC

Clearance details

Applicant: Biocore9, LLC
Product code: Code KXA
Advisory panel: Orthopedic
Date received: 2020-05-06
Decision date: 2021-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whippany, NJ, 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.