Cleared Traditional

K003662 - SPINE WORKS COLLAR

K003662 is an FDA 510(k) clearance for SPINE WORKS COLLAR, manufactured by Spine Works. The device is a Class 2 Neurology device with product code HAX cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K003662 · Spine Works · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
223d
Days
Class 2
Risk

K003662 is an FDA 510(k) clearance for the SPINE WORKS COLLAR. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by Spine Works (Traverse City, US). The FDA issued a Cleared decision on July 9, 2001 after a review of 223 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K003662

510(k) Number K003662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2000
Decision Date July 09, 2001
Days to Decision 223 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
74d slower than avg
Panel avg: 149d · This submission: 223d
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 19
Devices cleared under the same product code (HAX) and FDA review panel - the closest regulatory comparables to K003662.
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
K071173 · Ossur Americans (Formerly the Jerome Group) · May 2007
RESOLVE OPEN BACK HALO RINGS
K051918 · Jerome Medical · Aug 2005
JEROME GLASS RING
K023959 · The Jerome Group, Inc. · Feb 2003
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
K980689 · Friddle'S Orthopedic Appliances, Inc. · Feb 1999
J TONGS
K930021 · Jerome Medical · Dec 1995
ACE CERVICAL TRACTION HALOZS, TONGS & PINS
K954069 · Ace Medical Co. · Oct 1995
K003662 · SPINE WORKS COLLAR
Download PDF FDA Summary Spine Works