Cleared Traditional

K873693 - LEVTECH COMPOSITE TRACTION TONGS (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K873693 · Levtech, Inc. · Neurology device
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Feb 1988
Decision
144d
Days
Class 2
Risk

K873693 is an FDA 510(k) clearance for the LEVTECH COMPOSITE TRACTION TONGS. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by Levtech, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 5, 1988 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5960 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Levtech, Inc. devices

Submission Details

510(k) Number K873693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1987
Decision Date February 05, 1988
Days to Decision 144 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 148d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAX Tong, Skull For Traction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5960
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.