Cleared Traditional

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM

K121575 · Ortho Solutions Limited · Orthopedic
Sep 2012
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K121575 is an FDA 510(k) clearance for the OXFORD ANKLE FUSION NAIL(AFN) SYSTEM, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Ortho Solutions Limited (Prior Lake, US). The FDA issued a Cleared decision on September 14, 2012, 107 days after receiving the submission on May 30, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K121575 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2012
Decision Date September 14, 2012
Days to Decision 107 days
Submission Type Traditional
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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