VARUS AND VALGUS LEG HOLDER— 510(k) K873139

Name: FDA 510(k) clearance K873139
Creator: U.S. Food and Drug Administration
Published: 1987-09-16

Substantially Equivalent

Leonard Medical, Inc.

FDA 510(k) clearance K873139 for VARUS AND VALGUS LEG HOLDER, Substantially Equivalent on 1987-09-16. Applicant: Leonard Medical, Inc.. Device class: 1.

Clearance details

Applicant: Leonard Medical, Inc.
Product code: Code FWZ
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1987-08-10
Decision date: 1987-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntingdon Valley, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.