PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONG— 510(k) K852563

Name: FDA 510(k) clearance K852563
Creator: U.S. Food and Drug Administration
Published: 1985-06-28

Substantially Equivalent

The Huxley Instrument Corp.

FDA 510(k) clearance K852563 for PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONG, Substantially Equivalent on 1985-06-28. Applicant: The Huxley Instrument Corp.. Device class: 2.

Clearance details

Applicant: The Huxley Instrument Corp.
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1985-06-17
Decision date: 1985-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Penn Yan, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.