Cleared Traditional

K780763 - ENTRAX TRACTION UNIT (FDA 510(k) Clearance)

Class I Orthopedic device.

K780763 · Orthopedic Equipment Co., Inc. · Orthopedic device
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May 1978
Decision
8d
Days
Class 1
Risk

K780763 is an FDA 510(k) clearance for the ENTRAX TRACTION UNIT. Classified as Unit, Traction, Hip, Non-powered, Non-penetrating (product code HSR), Class I - General Controls.

Submitted by Orthopedic Equipment Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1978 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5890 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthopedic Equipment Co., Inc. devices

Submission Details

510(k) Number K780763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1978
Decision Date May 16, 1978
Days to Decision 8 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 122d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HSR Unit, Traction, Hip, Non-powered, Non-penetrating
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5890
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.