BIO-FIT HIP SYSTEM— 510(k) K854791

Substantially Equivalent

Richards Medical Co., Inc.

FDA 510(k) clearance K854791 for BIO-FIT HIP SYSTEM, Substantially Equivalent on 1986-02-27. Applicant: Richards Medical Co., Inc..

Clearance details

Applicant: Richards Medical Co., Inc.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1985-11-29
Decision date: 1986-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.