ACUFIT TOTAL HIP— 510(k) K904383

Substantially Equivalent

Acu Med, Inc.

FDA 510(k) clearance K904383 for ACUFIT TOTAL HIP, Substantially Equivalent on 1990-12-20. Applicant: Acu Med, Inc..

Clearance details

Applicant: Acu Med, Inc.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 1990-09-26
Decision date: 1990-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.