Cleared Traditional

PMT HALO SYSTEM

K090733 · Pmt Corp. · Neurology
Jul 2009
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K090733 is an FDA 510(k) clearance for the PMT HALO SYSTEM, a Tong, Skull For Traction (Class II — Special Controls, product code HAX), submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on July 28, 2009, 131 days after receiving the submission on March 19, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5960.

Submission Details

510(k) Number K090733 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HAX — Tong, Skull For Traction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5960

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