ECHO BI-METRIC PRESS-FIT STEMS— 510(k) K070274

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K070274 for ECHO BI-METRIC PRESS-FIT STEMS, Substantially Equivalent on 2007-04-03. Applicant: Biomet Manufacturing Corp.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 2007-01-29
Decision date: 2007-04-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.