Cleared Traditional

K980689 - FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM

K980689 is an FDA 510(k) clearance for FRIDDLE HALO SYSTEM, manufactured by Friddle'S Orthopedic Appliances, Inc.. The device is a Class 2 Neurology device with product code HAX cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K980689 · Friddle'S Orthopedic Appliances, Inc. · Neurology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K980689

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
Combination Product No
PCCP Authorized No
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.

HAX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HAX Tong, Skull For Traction

All 9
Devices cleared under the same product code (HAX) and FDA review panel - the closest regulatory comparables to K980689.
PMT HALO SYSTEM
K090733 · Pmt Corp. · Jul 2009
ACE CERVICAL TRACTION HALOZS, TONGS & PINS
K954069 · Ace Medical Co. · Oct 1995
NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE
K915530 · American Threshold Industries, Inc. · Aug 1992
PMT TRACTION TONGS
K871663 · Progress Mankind Technology · Jun 1987
MAYFIELD DISPOSABLE SKULL PINS
K853066 · Codman & Shurtleff, Inc. · Aug 1985
ACE UNIVERSAL TONG
K842680 · Buckman Co., Inc. · Sep 1984