Cleared Traditional

NOVOS-NAIL Limb Lengthening System (LLS)

K163653 · Smith & Nephew · Orthopedic
Oct 2017
Decision
294d
Days
Class 2
Risk

About This 510(k) Submission

K163653 is an FDA 510(k) clearance for the NOVOS-NAIL Limb Lengthening System (LLS), a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Smith & Nephew (Memphis, US). The FDA issued a Cleared decision on October 13, 2017, 294 days after receiving the submission on December 23, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K163653 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2016
Decision Date October 13, 2017
Days to Decision 294 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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