PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD— 510(k) K061564

Substantially Equivalent

Portland Orthopaedics Pty. , Ltd.

FDA 510(k) clearance K061564 for PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD, Substantially Equivalent on 2006-09-01. Applicant: Portland Orthopaedics Pty. , Ltd..

Clearance details

Applicant: Portland Orthopaedics Pty. , Ltd.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2006-06-05
Decision date: 2006-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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.