UNI-POLAR HEAD— 510(k) K896580

Name: FDA 510(k) clearance K896580
Creator: U.S. Food and Drug Administration
Published: 1990-02-15

Substantially Equivalent

Richards Medical Co., Inc.

FDA 510(k) clearance K896580 for UNI-POLAR HEAD, Substantially Equivalent on 1990-02-15. Applicant: Richards Medical Co., Inc.. Device class: 2.

Clearance details

Applicant: Richards Medical Co., Inc.
Product code: Code LZY
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1989-11-17
Decision date: 1990-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZY

product code LZY

Injury: 431
Total: 431

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.