Cleared Traditional

VERTETRAC (K771988) - FDA 510(k) Clearance

Class I Neurology device.

K771988 · Ballert Orthopedic Corp. · Neurology device
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Feb 1979
Decision
470d
Days
Class 1
Risk

K771988 is an FDA 510(k) clearance for the VERTETRAC. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Ballert Orthopedic Corp. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1979 after a review of 470 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Ballert Orthopedic Corp. devices

Submission Details

510(k) Number K771988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1977
Decision Date February 01, 1979
Days to Decision 470 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
322d slower than avg
Panel avg: 148d · This submission: 470d
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.