Cleared Traditional

OSTEOMED NEURO RONGEUR

K131851 · Osteomed · Neurology
Dec 2013
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K131851 is an FDA 510(k) clearance for the OSTEOMED NEURO RONGEUR, a Rongeur, Manual (Class II — Special Controls, product code HAE), submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on December 6, 2013, 168 days after receiving the submission on June 21, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number K131851 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2013
Decision Date December 06, 2013
Days to Decision 168 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAE — Rongeur, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4840