ZEE TRACTION SPLINT— 510(k) K813016

Name: FDA 510(k) clearance K813016
Creator: U.S. Food and Drug Administration
Published: 1981-11-24

Substantially Equivalent

Zee Medical Products Co., Inc.

FDA 510(k) clearance K813016 for ZEE TRACTION SPLINT, Substantially Equivalent on 1981-11-24. Applicant: Zee Medical Products Co., Inc.. Device class: 1.

Clearance details

Applicant: Zee Medical Products Co., Inc.
Product code: Code HST
Device class: Class 1
Regulation: 21 CFR 888.5850
Advisory panel: Orthopedic
Date received: 1981-10-27
Decision date: 1981-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HST

product code HST

Other: 1
Total: 1

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.