CL UNIVERSAL HIP DEVICE— 510(k) K885146

Substantially Equivalent

Lima Intl. Corp.

FDA 510(k) clearance K885146 for CL UNIVERSAL HIP DEVICE, Substantially Equivalent on 1989-04-24. Applicant: Lima Intl. Corp..

Clearance details

Applicant: Lima Intl. Corp.
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 1988-12-15
Decision date: 1989-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: E Providence, RI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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.