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) Official FDA 510(k) Summary (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.

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
211d slower than avg
Panel avg: 149d · 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 18
Devices cleared under the same product code (HAX) and FDA review panel - the closest regulatory comparables to K980689.
RESOLVE OPEN BACK HALO RINGS
K051918 · Jerome Medical · Aug 2005
JEROME GLASS RING
K023959 · The Jerome Group, Inc. · Feb 2003
SPINE WORKS COLLAR
K003662 · Spine Works · Jul 2001
J TONGS
K930021 · Jerome Medical · Dec 1995
ACE CERVICAL TRACTION HALOZS, TONGS & PINS
K954069 · Ace Medical Co. · Oct 1995
BREMER IMAGING TONGS-MRI MODEL
K924606 · Bremer Medical, Inc. · Sep 1993
K980689 · FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
Download PDF FDA Summary Friddle'S Orthopedic …