Cleared Traditional

SYNTHES SYNSONIC ULNA NAIL

K131984 · Synthes (Usa) · Orthopedic
Mar 2014
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K131984 is an FDA 510(k) clearance for the SYNTHES SYNSONIC ULNA NAIL, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on March 31, 2014, 276 days after receiving the submission on June 28, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K131984 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2013
Decision Date March 31, 2014
Days to Decision 276 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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