Cleared Traditional

TELEGRAPH? EVOLUTION Humeral Nailing System

K200127 · FH Industrie · Orthopedic
Oct 2020
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K200127 is an FDA 510(k) clearance for the TELEGRAPH? EVOLUTION Humeral Nailing System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by FH Industrie (Quimper Finistere, FR). The FDA issued a Cleared decision on October 1, 2020, 254 days after receiving the submission on January 21, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K200127 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2020
Decision Date October 01, 2020
Days to Decision 254 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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