Cleared Traditional

K781445 - SPREADER (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K781445 · Orthopedic Equipment Co., Inc. · General & Plastic Surgery device
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Sep 1979
Decision
400d
Days
Class 1
Risk

K781445 is an FDA 510(k) clearance for the SPREADER. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Orthopedic Equipment Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Orthopedic Equipment Co., Inc. devices

Submission Details

510(k) Number K781445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1978
Decision Date September 27, 1979
Days to Decision 400 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
286d slower than avg
Panel avg: 114d · This submission: 400d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAD Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.