Cleared Traditional

INION FREEDOMPIN

K133932 · Inion OY · Orthopedic
Apr 2014
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K133932 is an FDA 510(k) clearance for the INION FREEDOMPIN, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on April 11, 2014, 109 days after receiving the submission on December 23, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K133932 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2013
Decision Date April 11, 2014
Days to Decision 109 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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