MODEL 668, TRACTION SPLINT, ADULT— 510(k) K864765

Name: FDA 510(k) clearance K864765
Creator: U.S. Food and Drug Administration
Published: 1986-12-17

Substantially Equivalent

Ferno-Washington, Inc.

FDA 510(k) clearance K864765 for MODEL 668, TRACTION SPLINT, ADULT, Substantially Equivalent on 1986-12-17. Applicant: Ferno-Washington, Inc.. Device class: 1.

Clearance details

Applicant: Ferno-Washington, Inc.
Product code: Code HST
Device class: Class 1
Regulation: 21 CFR 888.5850
Advisory panel: Orthopedic
Date received: 1986-12-05
Decision date: 1986-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, OH, 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.