Cleared Special

PINIT SMALL BONE FUSION SYSTEM

K140617 · Arthrosurface, Inc. · Orthopedic
Apr 2014
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K140617 is an FDA 510(k) clearance for the PINIT SMALL BONE FUSION SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on April 25, 2014, 45 days after receiving the submission on March 11, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K140617 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2014
Decision Date April 25, 2014
Days to Decision 45 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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