Cleared Special

T2 GREATER TROCHANTER NAIL

K101438 · Howmedica Osteonics Corp. · Orthopedic
Jun 2010
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K101438 is an FDA 510(k) clearance for the T2 GREATER TROCHANTER NAIL, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on June 17, 2010, 24 days after receiving the submission on May 24, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K101438 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2010
Decision Date June 17, 2010
Days to Decision 24 days
Submission Type Special
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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