Cleared Traditional

OSSIO? Pin Product Family

K181180 · OSSIO , Ltd. · Orthopedic
Jan 2019
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K181180 is an FDA 510(k) clearance for the OSSIO? Pin Product Family, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on January 10, 2019, 253 days after receiving the submission on May 2, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K181180 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2018
Decision Date January 10, 2019
Days to Decision 253 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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