Cleared Traditional

K813016 - ZEE TRACTION SPLINT

K813016 is the FDA 510(k) clearance for ZEE TRACTION SPLINT by Zee Medical Products Co., Inc.. It is a Class 1 Neurology device (product code HST) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K813016 · Zee Medical Products Co., Inc. · Neurology device
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Nov 1981
Decision
28d
Days
Class 1
Risk

K813016 is an FDA 510(k) clearance for the ZEE TRACTION SPLINT. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Zee Medical Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.5850 - the FDA neurology 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: 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 Zee Medical Products Co., Inc. devices

Submission Details

510(k) Number K813016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1981
Decision Date November 24, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HST Apparatus, Traction, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5850
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.

Regulatory Peers - HST Apparatus, Traction, Non-powered

All 12
Devices cleared under the same product code (HST) and FDA review panel - the closest regulatory comparables to K813016.
TRACTION-STEEL FRAMING SYSTEM
K823395 · Orthopedic Systems, Inc. · Dec 1982
FOREARM REDUCTION UNIT
K823392 · Orthopedic Systems, Inc. · Nov 1982
TENSOPLAST SKIN TRACTION KIT
K820612 · Smith & Nephew, Inc. · Mar 1982
UPPER EXTREMITY TRACTION DEVICE
K803021 · Orthopedic Systems, Inc. · Dec 1980
OCTAGONAL ALUMINUM FRAMING SYSTEM
K790729 · Orthopedic Systems, Inc. · May 1979
TRACTION UNITS
K780228 · Biomet, Inc. · Feb 1978