BDH FEMORAL COMPONENT— 510(k) K821343

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K821343 for BDH FEMORAL COMPONENT, Substantially Equivalent on 1982-06-03. Applicant: Intermedics Orthopedics.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1982-05-05
Decision date: 1982-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.