Cleared Special

RESOLVE OPEN BACK HALO RINGS

K051918 · Jerome Medical · Neurology
Aug 2005
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K051918 is an FDA 510(k) clearance for the RESOLVE OPEN BACK HALO RINGS, a Tong, Skull For Traction (Class II — Special Controls, product code HAX), submitted by Jerome Medical (Moorestown, US). The FDA issued a Cleared decision on August 17, 2005, 33 days after receiving the submission on July 15, 2005. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5960.

Submission Details

510(k) Number K051918 FDA.gov
FDA Decision Cleared 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

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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