Cleared Traditional

K090733 - PMT HALO SYSTEM

K090733 is an FDA 510(k) clearance for PMT HALO SYSTEM, manufactured by Pmt Corp.. The device is a Class 2 Neurology device with product code HAX cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K090733 · Pmt Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
131d
Days
Class 2
Risk

K090733 is an FDA 510(k) clearance for the PMT HALO SYSTEM. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on July 28, 2009 after a review of 131 days - within the typical 510(k) review window.

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 - K090733

510(k) Number K090733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2009
Decision Date July 28, 2009
Days to Decision 131 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
18d faster than avg
Panel avg: 149d · This submission: 131d
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 K090733.
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
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
K090733 · PMT HALO SYSTEM
Download PDF FDA Summary Pmt Corp.