Cleared Traditional

SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM

K103002 · Synthes (Usa) · Orthopedic
Mar 2011
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K103002 is an FDA 510(k) clearance for the SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM, 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 March 2, 2011, 145 days after receiving the submission on October 8, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K103002 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 2010
Decision Date March 02, 2011
Days to Decision 145 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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