Cleared Special

K051918 - RESOLVE OPEN BACK HALO RINGS

K051918 is an FDA 510(k) clearance for RESOLVE OPEN BACK HALO RINGS, manufactured by Jerome Medical. The device is a Class 2 Neurology device with product code HAX cleared through the Special 510(k) pathway after a 33-day FDA review.

K051918 · Jerome Medical · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
33d
Days
Class 2
Risk

K051918 is an FDA 510(k) clearance for the RESOLVE OPEN BACK HALO RINGS. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by Jerome Medical (Moorestown, US). The FDA issued a Cleared decision on August 17, 2005 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5960 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K051918

510(k) Number K051918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2005
Decision Date August 17, 2005
Days to Decision 33 days
Submission Type Special
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
116d faster than avg
Panel avg: 149d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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 K051918.
PMT HALO SYSTEM
K090733 · Pmt Corp. · Jul 2009
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
K071173 · Ossur Americans (Formerly the Jerome Group) · May 2007
JEROME GLASS RING
K023959 · The Jerome Group, Inc. · Feb 2003
SPINE WORKS COLLAR
K003662 · Spine Works · Jul 2001
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
K980689 · Friddle'S Orthopedic Appliances, Inc. · Feb 1999
J TONGS
K930021 · Jerome Medical · Dec 1995
K051918 · RESOLVE OPEN BACK HALO RINGS
Download PDF FDA Summary Jerome Medical