Cleared Traditional

FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM (K980689) - FDA 510(k) Clearance

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

K980689 · Friddle'S Orthopedic Appliances, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
360d
Days
Class 2
Risk

K980689 is an FDA 510(k) clearance for the FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by Friddle'S Orthopedic Appliances, Inc. (Honea Path, US). The FDA issued a Cleared decision on February 18, 1999 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Friddle'S Orthopedic Appliances, Inc. devices

Submission Details

510(k) Number K980689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1998
Decision Date February 18, 1999
Days to Decision 360 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 148d · This submission: 360d
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.