Cleared Traditional

SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)

K120083 · Synthes (Usa) · Orthopedic
Feb 2012
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K120083 is an FDA 510(k) clearance for the SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN), a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on February 8, 2012, 28 days after receiving the submission on January 11, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K120083 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2012
Decision Date February 08, 2012
Days to Decision 28 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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