Cleared Special

ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)

K130147 · Small Bone Innovations, Inc. · Orthopedic
May 2013
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K130147 is an FDA 510(k) clearance for the ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL), a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Small Bone Innovations, Inc. (Morrisville, US). The FDA issued a Cleared decision on May 3, 2013, 101 days after receiving the submission on January 22, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K130147 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2013
Decision Date May 03, 2013
Days to Decision 101 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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